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Office of Research Office of Sponsored Programs May 16, 2013 4333 Brooklyn Avenue NE Box 359472 Seattle, WA 98195-9472 206.543.4043 fax 206.685.1732 www.washington.edu/research/osp Washington State Attorney General Consumer Protection Division Grant Review Committee 800 5th Avenue, Ste. 2000 Seattle, WA 98104-3188 Dear Ladies and Gentlemen: The University of Washington is pleased to submit this letter in support of the application entitled "Chronic Pain Management and Marijuana Use: Science-based Education in Times of Legalization." This application was prepared by Dr. Beatriz H. Carlini from our Alcohol and Drug Abuse Institute. We present this application for your review and request support in the amount of $110,299 for the period October 01, 2013 through March 31, 2015. Thank you for your consideration. Sincerely, Lynette Arias Director Office of Sponsored Programs Please reference our #A85413 on all correspondence concerning this application. L A i

University of Washington's Alcohol and Drug Abuse Institute application to study marijuana and pain control

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The funds for this study and education outreach project came from a settlement between states including Washington and the pharmaceutical giant Pfizer. The purpose is to research current attitudes, information and practices related to using marijuana for pain control. The project will then use that background information to help train health care providers in the use of cannabis for pain control as well as the negatives associated with cannabis use.

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Page 1: University of Washington's Alcohol and Drug Abuse Institute application to study marijuana and pain control

Office of ResearchOffice of Sponsored Programs May 16, 2013

4333 Brooklyn Avenue NE Box 359472 Seattle, WA 98195-9472206.543.4043 fax 206.685.1732 www.washington.edu/research/osp

Washington State Attorney GeneralConsumer Protection DivisionGrant Review Committee800 5th Avenue, Ste. 2000Seattle, WA 98104-3188

Dear Ladies and Gentlemen:

The University of Washington is pleased to submit this letter in support of the application entitled"Chronic Pain Management and Marijuana Use: Science-based Education in Times ofLegalization." This application was prepared by Dr. Beatriz H. Carlini from our Alcohol andDrug Abuse Institute.

We present this application for your review and request support in the amount of $110,299 for theperiod October 01, 2013 through March 31, 2015.

Thank you for your consideration.

Sincerely,

Lynette AriasDirectorOffice of Sponsored Programs

Please reference our #A85413 on all correspondence concerning this application.

L A i

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Pfizer Project Proposal Application

Applicant Information

Organization Name: University of Washington

Primary Contact Person: Lynette Arias, Director, Office of Sponsored Programs Mailing Address: 4333 Brooklyn Ave NE, Box 359472City, State, Zip Code: Seattle, WA 98195-9472 County: King Phone and Email: 206-543-4043, [email protected]: 206-685-1732

Secondary Contact Person: Merrilee Gavigan, Administrator, Alcohol & Drug Abuse Institute Mailing Address: 1107 NE 45th St., Suite 120, Box 354805 City, State, Zip Code: Seattle, WA 98105-4631 County: King Phone and Email: 206-543-0937, [email protected]: 206-543-5473

Organization Type

侊501 c3 Private Non-Profit侊Tribal Organization侊Local, County, or State Government AgencyX Public/State Controlled Institution of Higher Education

Business Information

Tax Identification Number (TIN): 91-6001537 Uniform Business Identifier (UBI): 178 019 988

Does your organization currently receive funding from the AGO or any other state or federal government agency?

X Yes 侊No If yes, list the contracts by project title, contract number, and funding amount:

FEDERAL FUNDING Alcohol Effects on Cognitive & Affective Mediation of Women's Decision Making

5 R01 AA014512-09 540,318

Integrating Behavioral Interventions in Substance Abuse Treatment

5 K23DA025678-04 179,226

Clinical Trials Network: Pacific Northwest Node 5 U10 DA013714-11 1,117,527Clinical Trials Network: Pacific Northwest Node 3 U10 DA013714-11S1 296,982

A Trial to Prevent Opioid Overdose: E.D. Based Intervention & Take-home Naloxone

5 R01 DA030351-02 554,542

Page 3: University of Washington's Alcohol and Drug Abuse Institute application to study marijuana and pain control

Increasing Post-discharge Follow Up among Hospitalized Smokers

QR852022amd2 22,539

The Healing of the Canoe (NCE) 5 R24 MD001764-08 542,451NW Frontier Addiction Technology Transfer Center 1002661_ADAI 51,300Northwest HIDTA Resource Center 28,000STATE FUNDING State of Washington Liquor Control Board, license fees, 171 funds Funds received April 2012 through March 2013

N/A 421,936

University of Washington 2011-13 biennium

N/A 114,365

Developing Overdose Prevention Programs for WA Celebrex CY Pres 58,712

Is the organization solely owned/operated by a current state employee? 侊Yes X No If yes, complete the Ethics Certification process at http://www.ethics.wa.gov.

How did you hear about available funds? 侊AGO Staff. If so, who and when: X Request for Proposal Notice 侊Other:

Project Proposal

Project Title: Chronic Pain Management and Marijuana Use: Science-Based Education in Times of Legalization.

Project Description.This project addresses gaps in science-based training and education in the area of chronic pain management and cannabis use. The ultimate goal is to increase awareness of treatment options to treat pain and other medical conditions, and decrease unnecessary suffering among people living with chronic pain in the state of Washington. The project will also provide information and education about medical conditions and populations for whom cannabis is not recommended, side-effects and risks.

Chronic pain is an emerging public health challenge aggravated by an aging U.S. population. The Institute of Medicine reports that 100 million Americans suffer from chronic pain conditions. A subset of this population is afflicted by intractable pain associated with cancer, neuropathic diseases, and central pain states (e.g., pain associated with multiple sclerosis). These conditions are often inadequately treated with available opiates, antidepressants and anticonvulsant drugs. Meanwhile, there is a growing body of evidence demonstrating the efficacy of cannabis in treating neuropathic pain, muscle spasms, fibromyalgia, and cacechexia, among other conditions.

In 1998, Washington voters approved the use of medical cannabis for various conditions, including intractable pain, defined as “pain unrelieved by standard medical treatments and medications” (RCW 69.51A) and set a corresponding set of quality control standards in place to

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assure the quality, consistency, and availability of medicinal cannabis for patients receiving chronic pain management.

The addition of medical cannabis to the menu of options to treat chronic pain in our State brings new hope to many Washingtonians. Washington has one of the highest rates of opiate-related mortality in the country, often the result of mismanagement or abuse of medications prescribed to alleviate chronic pain. Misconceptions about medical cannabis and the lack of science-based education for professionals hinder the benefits that the medical cannabis law can bring to those struggling with chronic pain. Health care providers are often reluctant to discuss marijuana use – for medical or recreational purposes - with their patients, due to lack of knowledge and training about the endocannabinoid system, other effects of marijuana, uncertainty about legal issues, and concern about abuse or dependence. Likewise, patients may be reluctant to ask their doctors about safe and effective marijuana use for medical purposes.

The passage of I-502 authorizing the sale of marijuana for recreational purposes seems to be creating even more confusion about the risks and benefits of medical cannabis. While the initiative does not amend or repeal the medical marijuana laws it distracts public opinion and health care providers from the medicinal properties of cannabis, including chronic pain management. Meanwhile, it is likely that the availability of legal marijuana from regulated state stores may motivate more Washingtonians to consider marijuana to treat pain and other conditions.

This project proposes development and provision of training and education resources on chronic pain and medical cannabis for the following target groups: a) staff and volunteers of community organizations that provide information and referral for a range of situations involving substance use and people struggling with chronic and acute conditions (Poison Center, Crisis Clinic and WA Recovery Helpline); b) health care providers and c) the general public.

Given the new legal status of marijuana in WA and the scarcity of training materials, project aims to assess training and information needs regarding marijuana and pain in the target groups above; develop science-based curriculum content appropriate for the needs of these three segments; evaluate the acceptability and feasibility of web-based training delivery of training and information about marijuana and pain treatment.

This proposal builds the decades of commitment by the Alcohol & Drug Abuse Institute (ADAI) to disseminate science-based information to researchers, policy makers, health care professionals, and the public. The ADAI is a focal point for alcohol and drug abuse research at the University of Washington and in the region, benefiting the citizens of Washington by expanding knowledge and providing information. ADAI has created numerous web-based resources for use by health care providers, researchers, and the public, such as StopOverdose.org.Screening & Assessment Instruments, and the NIDA Clinical Trials Dissemination Library. The project director for this project will be Dr. Beatriz Carlini, a Research Scientist at ADAI (see description and resume in this application.)

Planning ProcessThe planning process for the proposed project will be directed by Dr. Carlini with guidance from an advisory group. The advisory group will talk monthly and will include representatives from the WA Recovery Helpline, WA Poison Center, a community physician with expertise in palliative care, pain management and medical cannabis (Dr. Gregory Carter); an expert on

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treatment for marijuana abuse and dependence in adults and adolescents (Dr. Roger Roffman); and Dr. Dennis Donovan, Director of ADAI. We also plan to add members representing chronic pain patients and representatives of WA State Dept. of Health and the Division of Behavioral Health and Recovery (DBHR). The advisory group will be involved in all phases: development, implementation and evaluation.

The planning phase comprises three basic steps:

Step 1: Collect information on the training needs and preferred modes of training delivery of each segment involved in the project. As documented in the letters of support, WA Poison Center and The Crisis Clinic/WA Recovery Helpline agreed to participate on a staff needs assessment; we will conduct open discussions using a focus group format to assess their current knowledge of medical cannabis, chronic pain management, marijuana and opiate abuse.

Health Care Providers will be assessed through a brief online confidential and anonymous on-line survey. We will reach out to health care providers through ADAI’s existing contacts and networks, as well as other sources that we can access for low or no cost. ADAI has email lists of 3000+ recipients in Washington who subscribe to our email newsletters. We would also recruit via numerous websites and blogs managed by the ADAI Library, and use Facebook and Twitter accounts to publicize the survey. We obtained permission to post a notice recruiting participants on website and Facebook page of HEAL-WA, a statewide service that provides free access to evidence-based medical databases and journals to health providers in Washington. As of November 2012, HEAL-WA had 19,104 registered users in Washington, 12.8% of health professionals in the state. Finally, we will contact professional associations to place a notice in their newsletters or distribute to members via email lists, e.g. WA State Medical Association; WA Academy of Physician Assistants; WA Association of Naturopathic Physicians; WA State Nursing Association; and the WA State Pharmacy Association.

The results of the health care providers` assessment will be limited in their representativeness but will be helpful to identify the training needs of those more interested in the topic and therefore most likely to enroll in training about medical cannabis and chronic pain.

We will assess the education and information needs of the general public on chronic pain and medical cannabis by collecting information about the most common questions, misconceptions and challenges they face when interacting with patients or callers among the professional groups mentioned above.

The needs assessment will be conducted by Dr. Carlini with the assistance of Jennifer Velotta, a master’s level professional with extensive experience in telephone-based information and referral services.

Step 2: Identifying the training and educational materials already available. Preliminary searches indicate the existence of good web-based materials from other states, but not customized to the unique reality of Washington post-I-502 approval (see Educational Resources, at the end of Appendix B). The materials identified will be pre-screened in terms of content accuracy, source credibility, and presentation quality.

Step 3: Present the results of the needs assessment and a selection of the materials identified to the advisory group. The ADAI team and advisory committee will make decisions on which

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materials are adequate, which topics are not covered and training materials in need of development of adaptation.

Outreach Strategies ADAI is part of a new state working group addressing marijuana prevention, research, treatment, and evaluation. The work group comprises representatives from the state Dept. of Health (DOH), Liquor Control Board (LCB), Div. of Behavioral Health & Recovery (DBHR), Washington State Institute for Public Policy (WSIPP), and researchers from the UW and WSU. The group has confirmed that the existing ADAI website on marijuana is the appropriate venue for dissemination of web-based materials for the public. In this project, we propose to use that website as the “home” for additional, new educational resources about chronic pain and medical cannabis.

More specifically, our outreach approach will leverage ADAI and our partners’ resources and involve a variety of strategies, including:

a) Expansion of the website Marijuana: Science-based Information for the Public,http://adai.uw.edu/marijuana. Dr. Carlini is working with ADAI information sciences staff to customize the current content to the Washington State public. The website will function as a hub for all the training resources and will be expanded to include medical cannabis and pain management education to the three target audiences of this project.

b) Online (webinars, e-learning modules) and onsite training will be made accessible during working hours to staff and volunteers of the two community organizations selected - WA Recovery helpline/Crisis Clinic and WA Poison Center. (see letters of support).

c) Development and distribution of an educational brochure on chronic pain and medical cannabis through ADAI Clearinghouse. The WA Recovery helpline and WA Poison Center offer statewide free 24-hour services to WA state residents. These services are in daily contact with WA residents facing issues related to pain medication misuse; marijuana abuse and chronic untreated pain (see data on letters of support). The staff from these organizations will be encouraged to inform callers about materials available in ADAI website and clearinghouse, as well as utilize the knowledge and skills obtained in their training to better assist callers.

d) Health care providers – the most successful strategies utilized in the needs assessment phase will also be utilized to disseminate the availability of free training on chronic pain and medical cannabis. We will work with the UW Continuing Medical Education Department to obtain CME accreditation for the training modules as a way to increase the likelihood the training will be utilized by our target audience.

Curriculum or Approach This project will provide scientific-based information and utilize evidence-based approaches. The training content will offer a balanced, non-moralistic approach to present up-to-date information on medicinal cannabis, other medications indicated for pain management; chronic, acute and untreatable pain prevalence and definitions; and abuse and dependence potential of substances used to treat pain, including cannabis.

Our team of physicians and researchers with strong track records on the areas of pain management, medical cannabis and marijuana abuse and dependence will work with community members of the advisory group to offer education and training customized to respond to needs of each target audience.

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Based on assessment of information needs and preferred format, we anticipate that:

The training for staff and volunteers of the Recovery Helpline and Poison Center will include but not be limited to:

x Education on chronic pain, treatment options and potential of abuse and dependence of medicines available, including opiates and cannabis

x How to communicate about the benefits, risks and indication of medical cannabis for treatment of chronic pain

The training for health care professionals will include but not be limited to: x Basic science on the endocannabinoid system and clinical pharmacology of cannabis x Complete review of drug interactions and side effects x Thorough review of all relevant side effects, including instruction on how to counsel a

patient regarding timing of safety for driving with respect to cannabis dosing, how to properly and safely store medicinal cannabis

x How to do a basic risk assessment and approach to a patient at risk for addictive behavior with respect to medicinal cannabis

x Clinical applications of cannabinoids, review of safety, efficacy, and specific conditions legally authorized to be treated with medical cannabis (RCW 69.51A)

x Information on strains of cannabis, ingestion methods, and dosing x Condition specific information x State and federal legal information

The goal of the health care professional training will be to expand their role from referral agents to informed agents, prepared to answer patients’ questions with updated scientific evidence. As part of this goal, we hope that the scientific evidence provided during the trainings will “de-stigmatize” cannabis and increase providers’ comfort level in talking to patients about medical cannabis.

Activities or Services The specific activities and services will be defined based on the results of the planning process. We anticipate developing a four-module online tutorial to be utilized by staff and volunteers at the WA Recovery Help Line and WA Poison Center. The tutorials will be developed using the e-learning platform Articulate© which has the capability to insert quizzes, track users, and deliver content in interactive ways, using images and clips imported from other sources. We plan to follow up with site visits with our consultants to allow for an open discussion about the topics addressed.

We anticipate developing a series of webinars or e-learning modules for health care providers, addressing the topics outlined above, to be utilized by health care providers in WA.

We will also develop a color brochure for the general public, containing lay language and illustrations, print 5,000 copies, distributed through the ADAI Clearinghouse.

ADAI will host all these resources on the marijuana website and make them freely available to the general public in Washington. Resources from other states that are considered valuable by the project’s advisory group will be also uploaded, after permission is granted from the producing agency.

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Data from Google Analytics shows that in the first 24 months of operation, the ADAI marijuana website had 322,140 visits, with 11,990 visitors from Washington. Pages from the site have been shared 80 times (e.g. reposted to other sites). We believe that with the outreach strategies outlined above we should be able to generate at least 3,000 new visits from WA to the website and expect that at least 300 people (10%) would go through some of the online training provided.

Staffing levels and experience University of Washington Funds are requested to increase the FTE of Dr. Carlini and Ms. Velotta, and to cover a small portion of Dr. Roffman’s FTE. Requested funds do not supplant or reduce ADAI operating costs or services, and are not administrative costs.

Beatriz H. Carlini, PhD, MPH is a part-time Research Scientist at the UW Alcohol and Drug Abuse Institute (ADAI) and will be the project director for this project. Dr. Carlini coordinated and delivered health care provider training for the WA State Department of Health (Tobacco Cessation Resource Center) and for the Foundation of Care Management. She was co-investigator in two health-care provider web-based training programs, aimed to develop substance abuse screening, brief intervention and referral skills among clinicians. Her research has focused on clinician education in integrating tobacco cessation into routine care and the use of technology (telephone, web, Interactive Voice Response) to increase utilization and efficacy of tobacco dependence treatment, with a focus on underserved smokers.

Nancy Sutherland, MLS and Meg Brunner, MLIS are librarians and information specialists at ADAI. They have extensive experience in the development and management of a numerous websites and information systems to disseminate information to a variety of audiences, including students, researchers, clinicians, and the public. The librarians have developed a number of special information sites, including the National Drug Abuse Treatment Clinical Trials Network (CTN) Dissemination Library, the ADAI Screening & Assessment Instruments Database, and the WA State Substance Use Data & Resources site, which presents statistics and information by county for the entire state. Other projects include the development and management of the StopOverdose.org website, developed to inform Washington state residents about our 911 Good Samaritan Law and to train individuals in preventing and treating opioid overdose; and the Marijuana: Science-Based Information for the Public web site, developed to provide current evidence-based information about marijuana to the general public, with special sections for parents and teens.

Jennifer Velotta, MNPL, CDP, ICPS, Outreach Specialist, will assist the project director with needs assessment, development and delivery of training for staff and volunteers of the Recovery Helpline and WA Poison Center. She will also assist in the development of information materials for the general public. Ms. Velotta is especially suited for these tasks; her experience includes 6 years as Teen Line Coordinator for the Alcohol & Drug Helpline, and 3.5 years as Tobacco Prevention Coordinator for King County. In 2004, she became Manager of the WA State Alcohol/Drug Clearinghouse, and continued that role when the Clearinghouse moved to ADAI in August 2011. For the Clearinghouse, Jennifer selects, develops, and distributes materials about drug and alcohol abuse for a variety of audiences in Washington.

Dennis M. Donovan, PhD, Professor, UW Dept of Psychiatry & Behavioral Sciences and Director, UW Alcohol & Drug Abuse Institute will represent ADAI on the Advisory Board which will assist in setting the direction and policies of this project. Dr. Donovan has extensive clinical and research experience in the assessment and treatment of alcohol and drug problems,

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and in designing and testing science-based interventions. He has been the Director of ADAI since 1993 and has been a UW faculty member since 1981. Dr. Donovan has served as Principal Investigator on a number of federally-funded grants, including NIAAA’s Project MATCH, the NIAAA COMBINE Study, and the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN). He has published more than 230 articles, chapters, and books in the area of alcoholism and addictive behaviors. Dr. Donovan is also the assistant editor for the Americas for the journal Addiction, and has served as an ad-hoc reviewer for over 25 other peer-reviewed journals.

Roger A. Roffman, DSW, professor emeritus, has served on the faculty of the UW School of Social Work since 1972. One emphasis of Roffman’s research has been the design and evaluation of interventions in the field of substance abuse, with a particular focus on marijuana dependence. His studies of behavioral counseling interventions focus on supporting adults and adolescents who desire to change their behaviors. Roffman is co-editor of Cannabis Dependence: Its Nature, Consequences, and Treatment published in 2006 by Cambridge University Press. Roffman also maintains a private practice specializing in substance abuse counseling. Roffman was a co-sponsor of Initiative 502; he has written and lectured frequently about marijuana to a wide range of audiences. Dr. Roffman’s role in the project will be to assist on developing the training content, particularly about the law and policy in Washington State, and as a trainer in webinars about marijuana use, dependence and evidence-based interventions. He will also be part of the advisory group for the project.

Consultant

Gregory T Carter, MD, MS from Providence Medical Group in Southwest WA will support this project by serving as a consultant, reviewing training and educational materials, participating in webinars, and writing up cases with examples of clinical uses based on his numerous years in clinical practice. Dr. Carter is a physiatrist with subspecialty fellowship training in neuromuscular medicine and chronic pain. He did his pain management fellowship at the UW. He was one of the principal authors of former Governor Christine Gregoire’s petition to the Federal Drug Enforcement Agency to get cannabis rescheduled to a category II drug. Dr. Carter has advised the DOH in matters of physician behaviors in authorizing medical cannabis. He is a court-recognized expert witness in the area of cannabinoid pharmacology. Having co-authored over 157 peer-reviewed journal articles, Dr. Carter has extensive research experience, with much of his work focusing on the potential role of cannabis as a viable chronic pain management option for patients with a variety of conditions. Dr. Carter is also on the faculty of the UC Davis School of Medicine, as well as the UW SOM MEDEX Northwest Division (previously the Department of Rehabilitation Medicine).

Community Advisory Board Members

Robin Smith, MSW, CDP, Coordinator of the Washington Recovery Help Line, will represent the WRHP on the Advisory Board which will assist in setting the direction and policies of this project.

Jim Williams is the Executive Director, WA Poison Center, will represent the Washington Poison Center on the Advisory Board which will assist in setting the direction and policies of this project.

Relevance of Project to AGO Funding ObjectivesAs detailed in the Request for Proposal, this project directly addresses the goals of providing counseling on chronic pain management to Washington residents. The proposal targets the

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gaps in education, training and counseling skills among health care workers and educates the public on medical cannabis. This focus increases the chances that Washington residents suffering from chronic pain will be counseled on pain management and medical cannabis based on current scientific information.

The multiple target groups and modes of education and training we plan to provide at no cost to community members should allow underserved populations to readily access educational programming through whatever mechanism best suits their needs. The training and education we propose, webinar-based, is far less expensive, and potentially more cost-effective than in-person trainings. Lastly, education on pain management and medical cannabis is a unique and necessary service to the state, given the epidemic proportion of chronic pain patients in our state and the legalization of medical cannabis and recreational marijuana in Washington.

Benefits to WA Residents Suffering from Chronic PainThis project can benefit Washingtonians suffering from chronic pain, especially those afflicted by intractable pain and those experiencing problems from chronic opioid use:

x Patients afflicted by intractable chronic pain are often inadequately treated with available opiates, antidepressants and anticonvulsant drugs. This type of chronic pain is particularly common among patients with cancer-associated pain, neuropathic pain, and central pain states (e.g., pain associated with multiple sclerosis). Medical cannabis can be a beneficial option for these patients, but they often are not properly counseled about this option given the lack of training and misconceptions held by health care professionals about cannabis.

x Individuals suffering from chronic pain may experience severe problems as a consequence of chronic opioid-based therapy. These potential problems include not only addiction, but also behaviors potentially indicative of poor pain control (raising opioid dose on one’s own, which increases risk of overdose) and various forms of abuse and misuse of prescription opioids (e.g., forging prescriptions, going to multiple doctors to obtain opioids). These individuals have the right to learn accurate and scientifically updated information about medical cannabis, from adequately trained health care professionals.

Describe the demographics of the consumers you serve.Is the population: Statewide

What is the total number of constituents you expect to serve during this grant cycle?Comprehensive chronic pain and medical cannabis training will be provided and completed by at least 380 people: 80 through online trainings and 300 web-based. We believe that several thousand more will view education materials on the marijuana-dedicated ADAI website, including the archived webinars, request and receive print brochures and obtain counseling and education about chronic pain and medical cannabis via the WA Recovery Help Line and the Poison Center and via other health care providers.

Is this a:X New project 侊Expansion of existing project (Eligibility considered on a case by case basis) 侊Enhancement of a current project (Eligibility considered on a case by case basis) 侊Other: (describe)

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Project Date

October 1, 2013 – March 31, 2015

Project Budget

Salaries/Benefits: 77,358 Goods and Services (i.e., printing, production, consulting, etc.): 22,144 Advertising/Outreach (directly related to the project): 0 Travel: 770 Administrative Overhead (limited to 10%) 10,027 Total AGO Funding Request: 110,299

What percentage of your total project budget does AGO funding request represent? 100%

List type and amount of other funding sources for this project. N/A

Does your organization plan to sustain this project upon completion of this contract? Once training videos and other resources for are developed under this project, ADAI will make those resources available indefinitely on our existing website.

Findings from the needs assessment and evaluation of the training will inform planning for a Marijuana Helpline, a new service mandated in Initiative 502 in the following language: “A marijuana use public health hotline that provides referrals to substance abuse treatment providers, utilizes evidence-based or research-based public health approaches to minimizing the harms associated with marijuana use, and does not solely advocate an abstinence-only approach.” The new helpline will be funded by revenue from marijuana license and sales and administered by the DOH.

Assuming that the program is feasible and acceptable based on evaluation findings, we will submit future grant applications to organizations such as the state DOH, Centers for Disease Control, National Institute of Health, and Substance Abuse and Mental Health Services Administration. Preliminary data obtained from the evaluation of the three different education programs will provide essential information that will significantly increase the odds of funding success.

Organizational Structure

Administration: Beatriz Carlini, PhD, MPH, Research Scientist, UW Alcohol and Drug Abuse Institute ([email protected], 206-616-5880) Fiscal and Budget: Merrilee Gavigan, Administrator, UW Alcohol and Drug Abuse Institute ([email protected], 206-543-1901) Service Delivery: Beatriz Carlini, PhD, MPH, Research Scientist, UW Alcohol and Drug Abuse Institute ([email protected], 206-616-5880)

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Community Collaboration

We are partnering with two community organizations in the proposal, The Washington Poison Center and the Crisis Clinic/ Washington Recovery Help Line (letters of support are attached). They will participate in this project in two ways:

1) They will be part of the Advisory Board which will assist the project team in setting the direction and policies of this project.

2) Their respective call centers’ staff will: a) be consulted in terms of their training needs in the area of chronic pain and medical cannabis; b) participate in free training, delivered online or in person, during working hours, addressing chronic pain and medical cannabis and c) provide feedback on training impact on their knowledge and comfort level in assisting people with questions related to the training topics.

Project Evaluation

List two goals you expect to achieve as a result of this project. This project will increase awareness of medical cannabis as an option for treating chronic pain among citizens of Washington.

This project will provide up-to-date, science-based information via education programs to increase knowledge and counseling skills among health care professionals and potentially decrease unnecessary suffering among Washingtonians with chronic pain.

List two outcomes you expect to see as a result of achieving those goals. Participants in all education programs will significantly improve their knowledge about chronic pain and medical cannabis at the time of training and in follow-up 30 days later.

Participants in education programs will increase their level of clinical confidence and comfort in discussing medical cannabis as an option for chronic pain management among the population they serve.

Describe how you plan to measure and evaluate your project. The numbers of participants in each education session will be documented. Visitors to the ADAI marijuana website will be tracked, as will those who view education materials, and who begin and complete the training modules.

Evaluation will occur at three points:

1. Brief surveys prior to delivering educational programs about knowledge and attitudes to obtain a baseline measure. (SEE APPENDIX A)

2. Assessment immediately following educational programs knowledge and attitudes. Planned behavior changes in response to the training will be documented.

3. A subset of those trained will be contacted one month post-training to reassess knowledge and attitudes. .

For those accessing the web based training we will be able to track web utilization in great detail including the number of unique and returning visitors, which pages are viewed, and responses to post-training knowledge assessments.

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Have you applied for a similar grant in the past, and if so, to which entity, when, and how much funding did you apply for?ADAI received funding from the Attorney General in May 2012 for the amount of $58,712. That project, “Developing Overdose Prevention Programs for Washington State,” is ongoing through August 2013 (see http://stopoverdose.org website). The source of the funds was the Celebrex CY Pres Grant.

Application Submission Checklist

X Completed, signed and dated application. X (2) Letters of Support from collaborating organizations X Current organizational chart X Evidence of tax status X Resume for agency director and for lead project staff person X Budget detail in Excel

I certify that I have the authority to submit this proposal, and that the information in this proposal is true and accurate. If my organization is faith-based, I understand that federal and state law prohibit the use of public funds for religious worship, exercise, instruction or support of any religious establishment.

http://www.acf.hhs.gov/programs/ccb/law/state_faith_based.htmhttp://www.leg.wa.gov/LawsAndAgencyRules/constitution.htm

I understand that my organization will not receive reimbursement for any costs incurred in preparing this proposal. If awarded funding, I understand that our proposal will be incorporated into the final contract.

Printed Name and Title Lynette Arias, Director, UW Office of Sponsored Programs Signature (by entering name here, form is electronically signed)

Date

p g

05/16/2013

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Northgate Executive Center II | 9725 3rd Avenue NE | Suite 300 | Seattle WA 98115 Phone 206.461.3210 Fax 206.461.8368 Web www.crisisclinic.org

May 14, 2013 Beatriz H. Carlini, Ph.D., MPH Alcohol and Drug Abuse Institute University of Washington 1107 NE 45th Street, Suite 120 Seattle, WA 98105 Dear Dr. Carlini; This letter confirms our interest in partnering with University of Washington Alcohol and Drug Abuse Institute in the proposal “Chronic Pain Management and Marijuana Use: science-based education in times of legalization”, being submitted to the Attorney General Office. We understand that one of the goals of this project is to educate our Recovery Specialists, Mental Health Professionals, Crisis Line volunteer phone workers and Crisis Clinic staff on chronic, acute and intractable pain as well as on medical cannabis indications to manage chronic pain. The training will include the risks and counter-indications of medical cannabis, interactions with other substances, Marijuana dependence and abuse, among other topics selected.

Crisis Clinic offers telephone-based crisis intervention and information and referrals to community services for youth and adults in Seattle-King County, WA. The Washington Recovery Help Line (WRHL) is a 24-hour help line that provides emotional support and linkage to local treatment resources for individuals struggling with substance abuse, problem gambling and mental health issues. Thus, Crisis Clinic is accredited by Washington State as a chemical dependency provider. Since the WRHL started in July 2011, we have received 1,357 calls about marijuana and another 4,337 calls related to prescription and over-the-counter medications. We anticipate an increase in calls related to medical cannabis as our state residents become more comfortable in discussing this topic with the recent approval of I-502.

We will be involved in this project in two ways:

1. Robyn Smith, MSW, CDP, WRHL Coordinator, will be our representative to serve on the Advisory Board which will assist in setting the direction and policies of the project.

2. Our call center staff will be consulted in terms of their training needs in the area of

chronic pain and medical cannabis and will receive free training, delivered online or in person, during working hours, as part of this project. They will also be invited to provide feedback on training impact on their knowledge and skills to assist people with questions in this area.

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Northgate Executive Center II | 9725 3rd Avenue NE | Suite 300 | Seattle WA 98115 Phone 206.461.3210 Fax 206.461.8368 Web www.crisisclinic.org

We request $2,500 to partially compensate our agency for the extra staff hours needed in order not to disrupt our existing services. Our participation and support to this project is not contingent on this fee. We are excited to be part of this project and look forward to collaborating further. If you have any questions, do not hesitate to contact me at [email protected] or 206-436-2980. Cordially,

Kathleen Southwick Executive Director

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U N I V E R S I T Y O F W A S H I N G T O N SCH OO L O F M E D I C I N E

MEDEX Division Gregory T. Carter, MD, MS

Chronic Pain and Behavioral Medicine Neuromuscular Medicine

Hospice and Palliative Care e-mail: [email protected]

May 11, 2013

Beatriz H. Carlini, Ph.D., MPHAlcohol and Drug Abuse InstituteUniversity of Washington1107 NE 45th Street, Suite 120Seattle, WA 98105

Dear Dr. Carlini:

I am most honored by your invitation to participate in your project "Chronic Pain Managementand Marijuana Use: science-based education in times of legalization", which aims to provide training to health services workers and the general public about chronic pain management and marijuana. My reply is a fervent “Yes, I would be honored to assist you!”

You have my complete and enthusiastic endorsement and I will support this project by reviewing training and educational materials, participating in webinars, writing up of cases showing examples of clinical uses, based on my clinical experience. You will be able to use this and other materials I may provide, in the training program that you are developing. I do believe my research and scientific writing skills will be of significant value to you as you carry out this grant project.

For the purposes of supporting your grant, I will provide more of my background here for you. As you know I have a strong interest in this area, and my medical training is in physiatry, with subspecialty fellowship training in neuromuscular medicine and chronic pain. I did my pain management fellowship training at the University of Washington under the tutelage of Dr. John Loeser. I have worked closely with the State of Washington previously in this area as I was one of the principle authors of former Governor Christine Gregoire’s petition to the Federal Drug Enforcement Agency to get cannabis (marijuana) re-scheduled to a category II drug. I have also advised the Department of Health in matters relating to physician practices in this area and I am a court-recognized expert witness in the area of cannabinoid pharmacology, testifying on behalf of the State of WA as well as private citizens,

I have extensive research experience, having currently co-authored 157 peer reviewed journal publications. Many of these publications examine the potential role of cannabis as a viable chronic pain management option for patients with neuromuscular disease, including amyotrophic lateral sclerosis (ALS), Charcot Marie Tooth disease (CMT) and various forms of muscular dystrophy, among others. I was the first investigator to report the effectiveness of cannabis in treating ALS and I was also among the first investigators to document the severity of pain associated with these disorders, most of which had previously been described in medical texts as "painless." For this work I was honored this past year by receiving the Distinguished Researcher Award from the American Association of Neuromuscular and

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2

Electrodiagnostic Medicine. I am also a past recipient of the Best Research Paper Award from the American Academy of Physical Medicine and Rehabilitation (PM&R). Thus I believe I can bring some valuable skills assist you with this project, which aims to develop and delivers training and educational materials about chronic pain and cannabis to health services workers and the general public. This project has the potential to improve the quality of life of tens of thousands of people living with chronic pain,which I find extremely valuable and important. As you well know this is an area surrounded by prejudice, misconception and gross misinformation. The recent legalization of marijuana use for recreational purposes will likely make the discussion of this topic a more frequently occurring event among patients and local and statewide health services providers. The medical/health care community needs to be better prepared to address it.

In return for my services I would request co-authorship on publications that arise from this project, of which I will assist in the writing and editing of, as well as submitting to medical journals. I also request a $3,000 (three thousand dollars in US funds) consultant fee. Knowing your background and skills, I have no doubt you will be successful with this project and I very much look forward to being a part of it. I am also enclosing a CV with this letter.

With warm regards, Gregory T Carter, MD Gregory T. Carter, MD, MSContact information:(360) 330-8626 [main office](360) 388-0534 [cell phone/pager][email protected] [academic e-mail][email protected] [clinic e-mail]

GTC:tas

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Alcohol and Drug Abuse Institute Functional Organizational Chart

Dennis M. Donovan, PhD Director

Nancy Sutherland, MLS Associate Director

Director, Information Services

John Neumaier, MD, PhD Associate Director

Director, Extramural Research

Merrilee Gavigan Administrator

Therese Grant, PhD Associate Director

Director, Fetal Alcohol & Drug Unit (FADU)

Director, WA State Parent-Child Assistance

Program (PCAP) Small Grants Program

Fetal Alcohol & Drug Unit (FADU)

x FASD Legal x FASD Experts

Parent-Child Assistance Program

Library Services Web and Listserv Clearinghouse Continuing Education Coordination (NATTC) IT and Network Administration

Fiscal Management Grants Management

Personnel Management, Secretarial/Office Support

FADU and PCAP Research, Clinical, and Consultative

Staff and Students

ADAI Research Scientists

Research Projects and Contracts

CTN Research Staff and Investigators

Pacific Northwest Node and Regional

Research and Training Center

(RRTC) of the NIDA Clinical Trials

Network (CTN)

Research Project Staff and Students

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3917�University�Way�NE,�Box�351120,�Seattle,�WA�98195���

2013�

To�Whom�It�May�Concern:�

The�University�of�Washington,�as�an�agency�of�the�State�of�Washington,�is�exempt�from�federal�income�taxes�under�Section�115(1)�of�the�Internal�Revenue�Code�(IRC).��The�Internal�Revenue�Service�has�confirmed�this�status�in�a�letter�dated�July�12,�1972�(copy�attached).��It�should�be�noted�that�the�citation�used�in�the�letter�(IRC�Section�115�(a))�is�based�on�the�1954�IRC,�whereas�the�current�citation�refers�to�the�IRC�under�the�Tax�Reform�Act�of�1986.�

The�University�of�Washington�is�not�planning�to�apply�for�IRC�section�501�(c)�(3)�status.��Accordingly,�we�do�not�have�a�tax�determination�letter�indicating�such�status.��

If�you�have�any�questions,�please�contact�me�at�(206)�616Ͳ3003�or�[email protected]

Thank�you,�

�Julia�Shanahan�Tax�Director�University�of�Washington������

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Beatriz H. Carlini May 2013

[email protected]

Education

2005 - Master of Public Health, University of Washington, Department of Health Services, Social and Behavioral Sciences track.

1993-1995 - Post-Doctoral Training, Boston University School of Public Health Social and Behavioral Sciences Department, Boston, MA, USA

1986-1992 - Ph.D., Social Psychology, Pontifícia Universidade Católica, São Paulo, Brazil

1976-1980 - B.A., Universidade de São Paulo, São Paulo, Brazil. Major in Social Sciences

Academic Positions and Employment

Research Scientist, Alcohol and Drug Abuse Institute, University of Washington, Seattle, Washington; August 2010 – present

Associate Investigator, Clinical and Behavioral Sciences Department, Alere Wellbeing (formerly Free & Clear Inc.) Seattle, Washington; September 2009 – present

Research Scientist, Clinical and Behavioral Sciences Department, Free & Clear Inc.Seattle, Washington; September 2005 – August 2009

Contractor, Research and Design Department, at Free & Clear Inc. Seattle, Washington, February to August 2005

Graduate Research Assistant, Department of Psychiatry and Behavioral Sciences, University of Washington. Seattle, Washington; January to December 2006

Assistant Professor, Department of Preventive Medicine University of São Paulo School of Medicine, São Paulo, Brazil São Paulo, SP, Brazil; September 1997 to January 2000

Researcher, CEBRID (Brazilian Center on Drug Information) Psychobiology Department, Federal University of São Paulo . São Paulo, Brazil; 1986 - 1996

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Scholarships

2004 - Tobacco Scholarship in Public Health - American Legacy Foundation and University of Washington, School of Public Health. Support for tobacco-related studies during MPH training.

2003 - Tobacco Scholarship in Public Health - American Legacy Foundation and University of Washington, School of Public Health. Support for tobacco-related studies during MPH training.

1993-95 – CNPq - Conselho Nacional de Pesquisa. Scholarship to pursue Pos-Doctoral Training at Boston University School of Public Health.

1991-92 – CNPq - Conselho Nacional de Pesquisa. Scholarship to pursue Doctoral Degree in Social Psychology at Pontifícia Universidade Católica.

Teaching and mentoring experience

2010 - 2011 - Systems Change Specialist Contract with Foundation of Care Management: Training and Mentoring of 3 rural clinical teams in Alaska, Washington and Oregon State. Goals: needs assessment, plan and implement changes aimed to integrate tobacco use and cessation in the routine of care.

2005- 2008 – Training and Systems Change Coordinator Contract with Tobacco Cessation Resource Center (TCRC), Washington State Department of Health: Mentoring of 6 health care staff teams in Washington-based clinics and hospitals. Goals: needs assessment, plan and implement changes aimed to integrate tobacco use and cessation in the routine of care.

1998-2001 - Advisor PhD Student Cynthia Gazal Carvalho, Preventive Medicine Department, University of São Paulo School of Medicine

1999-2000 - Advisor Master of Sciences student Paulina Duarte, University of São Paulo School of Medicine.

2001-2005 - Advisor PhD student Paulina Duarte, University of São Paulo School of Medicine

2001 to 2005 - Instructor Drug Abuse Specialist Degree, Catholic University of Paraná, Curitiba, Brazil.

1997-2001 - Instructor Course - Health Services in Brazil for Medical Students, 3rd semester. Preventive Medicine Department, University of São Paulo School of Medicine.

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Grants Received

2011 - 2012 Principal Investigator ADAI Small Grants Program University of Washington Using the Internet to Recruit Immigrants with Limited English Proficiency for Tobacco Use and Alcohol-Related Disorders Screening: A Pilot Study Among Brazilian Immigrants.

2009- 2012 (no cost extension) Principal Investigator 5 R21 CA141568-02 (Carlini) NIH/NCI Re-Engagement in Evidence-Based Quitline Treatment for Low Income Smokers The purpose of this proposed study is to develop, refine and test the use of IVR technology as a means of increasing re-engagement of low income smokers in telephone support for tobacco cessation (quitlines).

2009- 2014 Co-investigator 5 R01 CA138936-02 (McDaniel) NIH/NCI Technology-Enhanced Quitline Services to Prevent Smoking Relapse The purpose of this study is to test the efficacy of IVR technology for enhancing telephone-based smoking cessation services to prevent smoking relapse and achieve abstinence interventions.

2011- 2016 Co-Investigator 1 R01 CA152093-01A1 (McIntosh) NIH-NCI Web-Assisted Tobacco Intervention with Community College Students The proposed study combines mixed methods of qualitative and quantitative research with a group randomized design to test the effectiveness of Web-Assisted Tobacco Interventions (WATI) with Community College students in Western New York.

2010- 2014 Co- Investigator 1 U01 HL105232-01 (Richter) NIH/NHLBI Increasing Post-discharge Follow-up Among Hospitalized Smokers The primary aim of this project is to test the effects of warm transfer versus fax referral on quitline enrollments, post-discharge counseling adherence and smoking cessation. The secondary aim of this project is to determine mediators of the treatment effects on enrollment, post-discharge counseling and cessation.

2009 - 2011 Co- Investigator

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271200900035C-2-0-1 (Stoner) NIDA/SBIR SBIRT, Screening, Briefly Intervene and Referral to Treatment The goal of the present project is to develop a web-based training program to instruct PCPs in screening, risk assessment and intervention for substance use disorders, SBIRT-PC.

2010 - 2012 Associate Director and Health System Specialist (Halperin) Public Health - Seattle & King County Smokefree Hospitals Initiative The goals of this project are support the institution of 100% smoke-free campus policies at University of Washington Medical Center (UWMC) and all other King County hospitals and affiliated clinics without an existing policies and pilot a systems change project to integrate evidence-based treatment of tobacco use and dependence at the UWMC campus that can be used as a basis for programs at other hospitals.

2008 - 2009 Co-Investigator PHS 2007-01 - CDC – SBIR Centers for Disease Control and Prevention Increasing Quitline Utilization with Multimedia Education, Phase II Principal Investigator: Kelly Carpenter

2007 Co-Investigator PHS 2007-01 - CDC – SBIR Centers for Disease Control and Prevention Increasing Quitline Utilization with Multimedia Education, Phase I Principal Investigator: Kelly Carpenter

2005 - 2007 Co-investigator NIH P30 CA023100-22 National Cancer Institute. Reach and Assist Underserved Smokers through Quitlines. Principal Investigator: Shu Hong Zhu

1999 - FAPESP – Fundação de Amparo à Pesquisa do Estado de São Paulo – Support for a Visiting Professor at University of São Paulo Preventive Medicine Department. (1999/01751-0)

1996-98 – Principal Investigator - FAPESP – Fundação de Amparo à Pesquisa do Estado de São Paulo. Alcohol and solvents related problems among youth: mortality, psychiatry morbidity, intoxication, accidents and social problems.

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1997 - WHO – World Health Organization - Program on Substance Abuse - Project: “Alcohol-related injuries in São Paulo city, 1994-95”.

Publications and Papers

B. Journal Articles and Chapters in English

1. Cerutti B, Stratton RM, Carlini BH, McDaniel AM, Kauffman RM. (2013) Utilization of interactive voice response (ivr) technology in clinical trials: what you should consider when selecting a vendor. Journal of Society of Clinical Research Associates;75:11-14.

2. Richter KP, Faseru B, Mussulman LM, Ellerbeck EF, Shireman TI, Hunt JJ, Carlini BH, Ayars CL, Cook DJ, Preacher KJ. (2012) Using "warm handoffs" to link hospitalized smokers with tobacco treatment after discharge: Study protocol of a randomized controlled trial. Trials. 2012 Aug 1;13(1):127. DOI:10.1186/1745-6215-13-127

3. Carlini BH, Ronzani TM, Martins LF, Gomide HP, de Souza IC. Demand for and availability of online support to stop smoking. Rev Saude Publica. 2012 Dec;46(6):1074-81. PubMed PMID: 23503543.

4. Carpenter KM, Carlini BH, Painter I, Mikko AT, Stoner SA. (2012). Refer2Quit: Impact of web-based skills training on tobacco interventions and quitline referrals. Journal of Continuing Education in the Health Professions 32:3: 187-95 DOI: 10.1002/chp.21144.

5. Carlini BH, McDaniel AM, Weaver MT, Kauffman RM, Cerutti B, Stratton RM, Zbikowski SM.(2012) Reaching out, Inviting back: Using Interactive Voice Response (IVR) technology to recycle relapsed smokers back to Quitline treatment – a randomized controlled trial. BMC Public Health 12(1):507. doi: 10.1186/1471-2458-12-507.

6. Witkiewitz K, Bush T, Magnusson B, Carlini BH, Zbikowski S. (2011) Trajectories of cigarettes per day during the course of telephone tobacco cessation counseling services: A comparison of missing data models. Nicotine & Tobacco Research Advance Access published December 16, 2011 doi: 10.1093/ntr/ntr291.

7. Stoltzfus K, Ellerbeck EF, Hunt S, Rabius V, Carlini B, Ayers, C, & Richter KP (2011). A pilot trial of proactive versus reactive referral to tobacco quitlines. Journal of Smoking Cessation, 6(2), 133–137. DOI 10.1375/jsc.6.2.133.

8. Carlini BH, Schauer, G, Zbikowski, S, Thompson, J. (2010) Using the Chronic Care Model to address tobacco in health care delivery organizations: a pilot experience in Washington State. Health Promotion Practice 15, 401-408.

9. Carlini BH, B, Zbikowski S, Javitz H, Deprey TM, Cummings S, Zhu S Telephone-Based Tobacco Cessation Treatment: Re-enrollment Among

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Diverse Groups. (2008) American Journal of Preventive Medicine. 35(1): 73-76.

10.Carlini BH, Patrick D; Santos V & Halperin A (2006) The Tobacco Industry’s Response To The Commit Trial: An Analysis Of Legacy Tobacco Documents. Public Health Reports 121:501-508.

11. Carlini-Marlatt B, Gazal-Carvalho C, Gouveia N & Marinho F. (2003). Drinking Practices and Other Health-Related Behaviors among Adolescents of São Paulo city, Brazil. Substance Use and Misuse 38(7): 905-932.

12. Medina-Mora ME; Carlini-Cotrim B & Madrigal E (2000) Alcohol Policies in developing countries: Latin America. Journal of Substance Use 5 (1): 47-55.

13. Room R, Carlini-Cotrim B, Gureje O, Jernigan D, Mäkelä K, Marshall M, Monteiro M, Medina-Mora ME, Parry C, Partanen J, Riley L & Saxena S. (2000) Alcohol Policies in developing societies: perspectives from a project. Journal of Substance Use 5: 2-5.

14. Carlini-Cotrim B; Chasin, AAM. (2000) Blood alcohol content (BAC) and deaths from external causes: A study in the Metropolitan area of São Paulo, Brazil Journal of Psychoactive Drugs 32(3): 269-275.

15. Carvalho VA; Pinsky ; Souza e Silva R; Carlini-Cotrim B. (1995) Drug and alcohol use and family characteristics: a study among Brazilian high-schools students. Addiction 90:65-72.

16. Carlini-Cotrim B. Inhalant use among Brazilian youths (1995) In: Epidemiology of inhalant abuse: an international perspective. NIDA Research Monograph 148.

17. Carlini-Cotrim B; Coelho G (1994-95). Identifying Risk Factors for Drug Abuse Among Portuguese Speaking Youth in the Boston Area: A Preliminary Assessment Using Key Informant Networks. International Quarterly of Community Health Education 15(3): 267- 277.

18. Carlini-Cotrim B. (1994) An Overview on Drug Abuse Prevention in Brazilian Schools. Drugs: Education, Prevention & Policy 1(3): 275-288.

19. Caetano R & Carlini-Cotrim B (1993). Perspectives on Alcohol Epidemiology Research in South America. Alcohol Health and Research World17(3): 244-250.

20. Carlini-Cotrim B; Carvalho V (1993). Extracurricular activities: are they an effective strategy against drug consumption? Journal of Drug Education 23(1): 97-104.

21. Carlini-Cotrim B. (1993) An overview on drug abuse prevention in Brazilian schools. In: Monteiro, M.G. & Inciardi, J. (eds.), Brazil-United States Binational Research (São Paulo, Brasil: CEBRID).

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22. Carlini EA ; Carlini-Cotrim B. (1993). Illicit use of Psychotropic substances among Brazilian students: 1987 and 1989 surveys. In: Monteiro, M.G. e Inciardi, J. (eds.), Brazil-United States Binational Research (São Paulo, Brasil; CEBRID).

23. Carlini-Cotrim B & Rosemberg F (1991) Dealing with psychotropic drugs in school textbooks: the case of Brazil. Contemporary Drug Problems Fall: 417-432.

24. Carlini EA; Carlini-Cotrim B ; Nappo S. (1990). Illicit use of Psychotropic Drugs in Brazilian cities:1987-1989, Epidemiologic Trends in Drug Abuse, NIDA, USA.

25. Carlini-Cotrim B e Carlini EA (1988). The use of solvents and other drugs among children and adolescents from a low socioeconomic background. A study in São Paulo, Brazil. International Journal of the Addictions. 23(11): 1145-1156.

26. Carlini-Cotrim B e Carlini, E.A. (1988). The use of solvents and other drugs among homeless and destitute children living in the streets of São Paulo city, Brazil. Social Pharmacology. 2(1): 51-62.

27. Carlini BH; Pires, MLN, Fernandes R; Masur J(1986). Alcohol use among adolescents in São Paulo, Brazil. Drug and Alcohol Dependence 18: 235-246.

Presentations in scientific meetings in North America (2005 to date)

Oral Presentation- McDaniel AM, Carlini BH, Stratton RN, Cerutti B, Monahan PO, Stump, Kauffman RM, Zbikowski SM. Automated Telephone Monitoring for Relapse Risk among Recent Quitters Enrolled in Quitline Services. 2011 Society for Research on Nicotine and Tobacco (SRNT) 17th Annual Meeting, Toronto, Ontario, Canada February 16 - 19, 2011

Poster - Carlini BH; Ronzani TM; Souza ICW and Gomide H. Web-Assisted Tobacco Interventions (WATIs) beyond mainstream languages: A review of support available for Brazilian smokers who want to quit. Consortium of Universities on Global Health (CUGH) 2010 Annual Meeting, Seattle, Washington, September 19th - 21st, 2010.

Poster – Carpenter K, Carlini BH, Dolan E & Mikko T. Refer2Quit: Web-based provider training in tobacco Quitline referral skills. Society of Behavioral Medicine Annual Meeting, Seattle, April, 2010.

Poster - Carlini BH, Schauer G, Zbikowski S & Thompson J. Integrating Tobacco Cessation Interventions into the Routine of Care in Rural Settings. The Value of Prevention: American College of Preventive Medicine 2009 Conference: Poster #39;February 11, 2009.

Oral Presentation – Carlini BH; Schauer GS, Zbikowski S and Thompson J. Addressing Tobacco Identification and Treatment in Health Delivery Organizations: A Pilot Experience. Society of Behavioral Medicine Annual Meeting, San Diego, May 2008.

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Oral presentation – Carlini BH, Yepassis-Zembrou P, Mahoney L, Padilla J , Heilman NJ and Adondakis S. “Hispanics and non-Hispanic quit rates among participants of New Mexico Helpline”, National Conference on Tobacco or Health, Minneapolis, October 2007.

Poster – Carlini B, Zbikowski S, Deprey M, Zhu SH and Cummins S. “Testing Methods for Re-engaging Smokers in Cessation Treatment”. National Conference on Tobacco or Health, Minneapolis, October 2007.

Oral Presentation – Carlini B, Carpenter K. Using the Web to Build Referral Skills among Clinicians. North American Quitline Consortium Annual Meeting, Minneapolis, October 2007.

Panel/Oral Presentation - Carlini BH, Zbikowski S, Deprey M, Zhu SH and Cummins S. “Testing Methods for Re-engaging Smokers in Cessation Treatment”. North American Quitline Consortium Annual Meeting, Minneapolis, October 2007.

Poster – Carlini BH, Bush T, Stewart T, Zbikowski S, Padilla P and Adondakis S. “What does this have to do with quitting smoking? Push & pull of asking sensitive questions of callers seeking tobacco treatment through Quitlines” World Conference on Tobacco or Health, Washington DC, May 2006.

Poster – Carlini BH, Halperin A, Santos V and Patrick D. The tobacco industry’s response to the commit trial: an analysis of legacy tobacco documents, Washington DC, May 2006.

Panel/Oral presentation – “You can hear the kids in the background: A qualitative study of QuitLine participants from Latino descent.” National Conference on Tobacco or Health, Chicago, May 2005.

Selected Presentations in International meetings and events (2000 to date)

Key Note speaker – “Online interventions”. Third Congress of Multidisciplinary Association for Drug Studies (ABRAMD), Bento Gonçalves, Rio Grande do Sul, Brazil, November 1, 2011.

Oral Presentation - Carlini BH, McDaniel A, Cerutti B, Kauffman R, Weaver M, Stratton R, Zbikowski S. “Reaching out, inviting back - Using Interactive Voice Response (IVR) technology to recycle low income relapsed smokers back to treatment – a randomized control trial”. 2011 UK National Smoking Cessation Conference, London, England, June 13th – 14th, 2011.

Invited Speaker - “E-Health – “Health interventions in the digital era.” Social Psychology and Public Health Seminar, Federal University of Juiz de Fora. November 23rd, 2009. Juiz de Fora, Minas Gerais, Brazil.

Invited Speaker - ” Phone-based support for tobacco cessation – state of the art” Federal University of Health Sciences of Porto Alegre. November 26st, 2009. Porto Alegre, RS, Brazil.

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Invited Speaker - “Prevention – state of art”. First Congress of ABRAMD (Associacao Brasileira de Estudos Multidisciplinares sobre drogas), August 6th 2008, São Paulo, SP, Brazil.

Invited Speaker - “Experience of Quitline Networks in North America” in “Using Phone Quitlines to support smoking cessation – experiences in Latin America and North America” session. First Latin American SRNT Congress and Second Iberoamerican Conference on Tobacco Control, , September 7th, 2007, Rio de Janeiro, Brazil.

Invited Speaker – “Drug Abuse Prevention – state of the art” . Forum Nacional sobre Drogas, SENAD, Brasília, DF, Brazil (National Drug Forum, by National Anti-Drug Secretary), November 24th, 2004, Brasilia, DF, Brazil

Invited Speaker - “Harm Reduction” August 18-19th 2001, Sociedad Chilena Psicoterapia de Familia, Santiago, Chile.

Invited Speaker - “Alcohol and Youth”. First International Symposium on Alcohol, Tobacco, Drugs and Health. June 1-3, 2000, Lisbon, Portugal.

Invited Speaker - “Substance abuse prevention – myths and reality”. First International Symposium on Alcohol, Tobacco, Drugs and Health. June 1-3, 2000, Lisbon, Portugal.

International Initiatives

2009 – Temporary Advisor – World Health Organization, Department of Mental Health and Substance Abuse (MSD)- E-Health and Substance Abuse, October 14-19. Role as temporary advisor included a) discuss the implementation of the project “E-health and Substance Abuse” to develop, test and disseminate eHealth technologies in the area of substance abuse and b) exchange recent experience and best evidence in e-health and examine the feasibility of pilot eHealth portals on substance abuse in Brazil, Mexico, Belarus and India.

2008 – Peer Grant reviewer – ZonMw, Netherlands (http://www.zonmw.nl/en)

1994-current – Advisor Scientific Advisory Network (SAN), MENTOR Foundation International – Non-profit organization with mission to prevent substance abuse among youth (www.mentorfoundation.org)Involves working with a multi-country group of experts to advice where and how to invest resources globally.

2005-2006 – Consultant Best Practices Initiative. Mentor Foundation International. Available at http://www.mentorfoundation.org/towards_best_practice.phpThis initiative aimed to illustrate evidence-based principles of substance abuse prevention projects using real-world examples. My responsibilities included establish contacts with more than 200 community organizations around the world, select best

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35 projects and develop description of them in partnership with each work team site. Special emphasis was given to highlight initiatives in developing societies.

2005 – Contractor Grandparents Project. Mentor Foundation UK, Adfam and GrandParents Plus Develop literature review presenting the state of the art on tools to support grandparents raising their grandkids, due to the absence of the biological parents. More details at http://www.mentorfoundation.org/projects.php?pg=1&id=91

2004-2006 – Project leader Join initiative Catholic University of Paraná, Curitiba, Brazil and Centre of Addiction and Mental Health, Toronto, Ontario, Canada. Coordination of website localization (www.virtual-party.org) to Brazilian teenagers. Activities included supervision of six Brazilian professionals and 4 Canadians in website translation, administration of surveys and focus groups among Brazilian youth, data analysis and development of a teacher workbook on how to use this prevention resource in Brazil. The web site is now available in Portuguese at http://www.pucpr.br/template.php?codlink=178

2005- Contractor National Anti-Drugs Secretary of Brazil (SENAD), Brasilia, Brazil Develop educational materials for parents, teachers, primary care providers, community leaders and adolescents on substance abuse issues, including tobacco and alcohol. The publications are available on line at http://www.senad.gov.br/ (click “Publicacoes”)

2005 – Member of Scientific Committee for the 1st Pan American Conference on Alcohol Policies, 28-30th November 2005, Brasilia, Brazil.

2003 - 2005, Coordination of partnership between Office of International Health, Centre of Addiction and Mental Health (CAMH), in Canada and Catholic University of Paraná, Curitiba, Brazil. Leadership on establishing an exchange program of professionals and graduate students between the two organizations, aiming to opportunities of international exposure to Brazilian and Canadian health professionals on substance-abuse issues.

2003, Site visit coordination of Office of International Health – Centre of Addiction and Mental Health (CAMH), Toronto Canada to Brazil. Included making contacts, organizing agenda and facilitating meetings between CAMH and Brazilian universities, research centers and federal government aimed to explore partnerships on tobacco, alcohol and substance abuse education, prevention and research.

2000 – 2002, Coordination and technical supervision Hospital Albert Einstein, Sao Paulo, Brazil. Idealization, content development and update of Portal www.einstein.br/alcooledrogas.This portal was the first of its kind in Brazil and had modules target to 3 different

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audiences: teachers (on-line drug education training), adolescents (editorials, on-line party, ask the expert) and health professionals (weekly updates on scientific findings).

2001– 2002, Senior Technical Advisor, MENTOR Foundation International Technical Development of Information Centre (IC) at portal www.mentorfoundation.org This IC aims to promote exchange of information on substance abuse prevention and health promotion among adults who work with youth around the world

1998-99 -President of Scientific Committee of the 13th Meeting of Brazilian Association of Alcohol and Other Drugs (ABEAD) ,August 15th-19th, Rio de Janeiro, 1999.

1999, Consultant UNDCP (United Nations Drug Abuse Control Program).External evaluator of Project AD/BRA/96/C88 – “Drug Use Prevention Program for Street children and adolescents”

1996- 1999 - Member, Editorial Group. APDS - Alcohol Policies in Developing Societies, Program on Substance Abuse/World Health Organization. Worked as member of editorial group representing 13 developing countries in the Americas, Asia and Africa. During these 4 years, the editorial group reviewed scientific evidence of effective policies on alcohol control, conducted site studies and wrote a book for policy makers of evidence-based policies for alcohol control in developing societies (see book citation in publication section).

1994-1995 - Temporary Advisor World Health Organization, Substance Abuse Department, Social Change and Mental Health (Obligation HQ/95/042834) Development of theoretical framework and guidelines for action to prevent inhalant abuse among children and adolescents from developing societies The project is published at Volatile Solvent Use – a strategy for community involvement. (1999). World Health Organization, Substance Abuse Department, Social Change and Mental Health, Geneva (WHO/HSC/SAB/99.8), 23 pages

Professional Offices Held

Vice-President (1991-1993 and 1997- 1999) Brazilian Association on the Studies of Alcohol and Other Drugs (ABEAD)

Peer reviewer of scientific journals

- Addictive Behaviors (USA) - American Journal of Preventive Medicine (USA) - Nicotine & Tobacco Research (USA) - Psychology of Addictive Behaviors (USA) - Journal of Health Psychology (USA) - Journal of Clinical Psychology in Medical Settings (USA) - Cadernos de Saúde Pública (Brazil) - Revista de Saúde Pública (Brazil)

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BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors.

Follow this format for each person. DO NOT EXCEED FOUR PAGES.

NAMEDonovan, Dennis M.

POSITION TITLE Professor

eRA COMMONS USER NAME (credential, e.g., agency login) ddonovanEDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.)

INSTITUTION AND LOCATION DEGREE (if applicable) MM/YY FIELD OF STUDY

Seattle University, Seattle, WA B.S. 06/70 Psychology Western Washington University, Bellingham, WA M.A. 12/72 Psychology University of Washington, Seattle, WA Ph.D. 12/80 Clinical Psychology

A. PERSONAL STATEMENT Dennis Donovan, Ph.D. is the director of the Alcohol and Drug Abuse Institute at the University of Washington (UW) and Professor in the Department of Psychiatry and Behavioral Sciences. Dr. Donovan has over 30 years experience as a direct service provider, clinical trainer and supervisor, program administrator, and clinical researcher in the alcohol and drug dependence field. He has expertise in assessment of addictive behaviors; screening, brief interventions and referral to treatment for alcohol and drug problems in medical settings; motivational and cognitive-behavioral interventions such as motivational interviewing, motivational enhancement, and relapse prevention therapies; mindfulness approaches; client-treatment matching; treatment outcome evaluation; clinical trials methodology; and services research. He has participated in development and manualization of behavioral prevention and treatment interventions and measures of treatment integrity, therapist competence, and implementation fidelity. He has been the site PI in a number of large-scale multisite clinical trials, including the NIAAA-funded Project MATCH and COMBINE Study. He has also been involved in NIAAA- and NIDA-funded trials of screening, brief intervention, and referral to treatment (SBIRT) targeting hazardous drinking and illicit drug use in primary care, trauma center, and emergency department settings. He is a PI of the Pacific Northwest Node and Regional Research and Training Center of the National Institute on Drug Abuse (NIDA) National Drug Treatment Clinical Trials Network (CTN), which translates efficacious, evidence-based substance abuse interventions to community-based treatment programs and providers where their effectiveness is evaluated. He will serve as a member of the proposed project’s Advisory Board and will provide expertise in every aspect of the study as a senior scientist in alcohol and drug use research. Specifically, he will collaborate on study and training design, training delivery, program evaluation, planning of analyses, interpretation of study results, contributing to the manuscripts, and dissemination of study findings. B. POSITIONS AND HONORS 1981 – present Assistant Professor (1981-1984), Associate Professor (1984-1994), Professor (1994-present), Department of Psychiatry & Behavioral Sciences, UW School of Medicine, Seattle 1981 – 1986 Assistant Chief, Alcohol Dependence Treatment Program, Seattle VA Medical Center, Seattle 1985 – 1991 Chief, Inpatient Section, Addictions Treatment Center, Seattle VA Medical Center, Seattle 1985 – 1992 Field Editor for Neuropsychology, Journal of Studies on Alcohol1985 – 1998 Member, Editorial Board, Journal of Studies on Alcohol1987 – 1993 Assistant Director, Addictions Treatment Center, Seattle VA Medical Center, Seattle 1987 – 1991 Member, NIAAA Clinical & Treatment Alcohol Psychosocial Research Review Group (IRG) 1988 – present Adjunct Associate Professor (1988-1994), Adjunct Professor (1994-present), Department of Psychology, University of Washington, Seattle 1988 – 1990 Secretary-Treasurer, Society of Psychologists in Addictive Behaviors 1989 – 1998 Principal Investigator, Seattle Clinical Research Unit, Matching Alcoholism Treatments to Client Heterogeneity (Project MATCH), National Institute on Alcohol Abuse and Alcoholism 1990 – 1992 Associate Editor, Psychology of Addictive Behaviors1991 – 1992 President, Society of Psychologists in Addictive Behaviors 1991 – 1996 Director, Interdisciplinary Fellowship Training Program in Substance Abuse Treatment, Addictions Treatment Center, Seattle VA Medical Center, Seattle 1993 – 1996 Associate Director, Center of Excellence in Substance Abuse Treatment and Education, Addictions Treatment Center, Seattle VA Medical Center, Seattle

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1993 – present Director, Alcohol and Drug Abuse Institute, University of Washington, Seattle 1996 – 1997 Acting Director, Center of Excellence in Substance Abuse Treatment and Education, Addictions Treatment Center, Seattle VA Medical Center, Seattle 1997 – 1998 Member, NIDA AIDS Behavioral Research Review Committee (IRG) 1997 – 2007 Principal Investigator, Seattle Clinical Research Unit, Pharmacological and Behavioral Treatment with Alcoholics (COMBINE), National Institute on Alcohol Abuse and Alcoholism 1998 – 2007 Member, Scientific Advisory Panel, Hazelden Foundation, Hazelden Institute - Butler Center

for Research and Learning, Center City, MN 1999 – present Fellow, Division 50 (Addictions), American Psychological Association (APA) 2001 – present Principal Investigator and Director, Pacific Northwest Node and Regional Research and

Training Center, NIDA National Drug Abuse Treatment Clinical Trials Network, University of Washington

2002 – present Assistant Editor, Addiction 2005 – 2009 Consulting Editor, Psychology of Addictive Behaviors

2009 – present Fellow, Division 28 (Psychopharmacology & Substance Abuse), APA 2011 – present Member, Editorial Board, Journal of Addiction Research & Therapy 2011 – present Board Member, Science and Management of Addictions Foundation, Seattle

Honors and awards Graduated summa cum laude, Seattle University, 1970; Alpha Sigma Nu (Jesuit Universities National Honor Society), 1969-1970; Outstanding Young Man of America, U.S. Jaycees, 1977; Certificate of Merit, Third Annual Government Employees Insurance Company (GEICO) Public Service Award Program in Alcoholism, 1983; Professional Services Award, Association of Veterans Administration Chief Psychologists, 1984; Elected member, International Committee on Alcohol, Drugs and Traffic Safety, 1992 C. SELECTED PEER-REVIEWED PUBLICATIONS Most recent (from a total of 185 peer-reviewed articles, 35 book chapters, and 5 books) 1. Donovan, D.M., Bigelow, G.E., Brigham, G.S., et al. Primary outcome indices in illicit drug dependence

treatment research: Systematic approach to selection and measurement of drug use endpoints in clinical trials. Addiction, 107(4): 694-708, 2012.

2. Price, C.J., Wells, E.A., Donovan, D.M., & Brooks, M. Implementation and acceptability of Mindful Awareness in Body-oriented Therapy in women's substance disorder treatment. Journal of Alternative and Complementary Medicine, 18(5): 1-9, 2012.

3. Donovan, D.M., & Witkiewitz, K. Relapse prevention: From radical idea to common practice. Addiction Research and Theory, 20(3), 204-217, 2012.

4. Price, C.J., Wells, E.A., Donovan, D.M., & Rue, T. Mindful Awareness in Body-oriented Therapy as an adjunct to women’s substance use disorder treatment: A pilot feasibility study. Journal of Substance Abuse Treatment, 43(1): 94-107, 2012.

5. Witkiewitz, K., Donovan, D.M., & Hartzler, B. Drink refusal training as part of a combined behavioral intervention: Effectiveness and mechanisms of change. Journal of Consulting and Clinical Psychology, 80(3): 440-449, 2012.

6. Donovan, D.M., Bogenschutz, M.P., Perl, H., et al. Study design to examine the potential role of assessment reactivity in Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED) Protocol. Addiction Science & Clinical Practice, 7:16, 2012.

7. Radin, S.M., Banta-Green, C.J., Thomas, L.R., Kutz, S.H., & Donovan, D.M. Substance use, treatment admissions, and recovery trends in diverse Washington State Tribal communities. American Journal of Drug and Alcohol Abuse, 38(5): 511–517, 2012.

8. Krupski, A., Joesch, J.M., Dunn, C., Donovan, D., et al. Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: Rationale, design, and methods. Addiction Science & Clinical Practice, 7: 27, 2012.

9. Zatzick, D., Donovan, D., Dunn, C., et al. Substance use and PTSD in trauma center patients receiving mandated alcohol SBI. Journal of Substance Abuse Treatment, 43: 410-417, 2012.

10. Donovan, D.M., Daley, D.C., Brigham, G.S., et al. Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): A multisite trial in the NIDA Clinical Trials Network. Journal of Substance Abuse Treatment, 44(1): 103-114, 2013.

11. Morasco, B.J., Turk, D.C., Donovan, D.M., & Dobscha, S.K. Prescription opioid misuse among patients with a history of substance use disorder. Drug and Alcohol Dependence, 127(1-3): 193-199, 2013.

12. Gueorguieva, R., Wu, R., Krystal, J.H., Donovan, D.M., & O’Malley, S.S. Temporal patterns of adherence to medications and behavioral treatment and their relationship to patient characteristics and treatment response. Addictive Behaviors, 38(5): 2119-2127, 2013.

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13. Zatzick, D.F., Donovan, D.M., Dunn, C., et al. Developing and implementing randomized trials targeting the sustained integration of alcohol screening and brief intervention services at US trauma centers. General Hospital Psychiatry, 35(2):174-180, 2013.

14. Donovan, D.M., Knox, P.C., Skytta, J.A.F., et al. Buprenorphine from detox and beyond: Preliminary evaluation of a pilot program to increase heroin dependent individuals' engagement in a full continuum of care. Journal of Substance Abuse Treatment, 44(4): 426-432, 2013.

15. Winhusen, T., Lewis, D., Adinoff, B., Brigham, G., Kropp, F., Donovan, D.M., et al. Impulsivity is associated with treatment non-completion in cocaine- and methamphetamine-dependent patients but differs in nature as a function of stimulant-dependence diagnosis. Journal of Substance Abuse Treatment, 44(5):541-547,2013.

D. RESEARCH SUPPORTOngoing Research Support 5 U10 DA013714-11 Donovan & Roll (PIs) 01/10/01 – 08/31/15 NIDA Clinical Trials Network: Pacific Northwest Node One of 13 regional centers in the NIDA Clinical Trials Network (CTN), which will evaluate effectiveness in community treatment agencies of drug abuse therapies with demonstrated efficacy. Role: PI 5 R24 MD001764-08 Donovan (PI) 09/30/05 – 02/28/14 NIMHD The Healing of the Canoe This collaborative project between the Suquamish and Port Gamble S’Klallam Tribes and the Alcohol and Drug Abuse Institute works in partnership to refine, implement, and evaluate a community-based and culturally congruent intervention to prevent or reduce alcohol and drug use/abuse, to increase youth’s connection with tribal culture, values, and traditions, and promote health among American Indian youth in tribal communities. Role: PI 5 R01 AA016102-05 Zatzick (PI) 08/01/07 – 07/31/13 NIAAA Disseminating Organizational SBI Services (DO-SBIS) at Trauma Centers The goal is to capitalize on the unique opportunity afforded by the 2005 the American College of Surgeons landmark resolution mandating alcohol screening and brief interventions in level I trauma centers, by taking early steps to insure high quality, evidence-based SBI services are implemented and outcomes are assessed. Role: Co-Investigator 5 R01 DA026014-05 Roy-Byrne (PI) 09/01/08 – 06/30/13 NIDA Brief Intervention in Primary Care for Problem Drug Use and Abuse The study has four aims: (1) to determine if brief intervention (BI) is effective in reducing drug use and increasing completed referral to treatment; (2) to test whether higher fidelity to a BI model that emphasizes motivational interviewing is more effective than lower fidelity; (3) to estimate the impact of BI on several public health outcomes; (4) to estimate the costs of the intervention, potential cost offsets, and incremental cost-effectiveness from the payer perspective based on health care service use and drug use frequency. Role: Co-Investigator1 R01 AA020252-01A1 Kaysen (PI) 02/10/12 – 01/31/17NIAAA Sequence of Symptom Change during AUD or PTSD Treatment for Comorbid PTSD/AUD The long-term objective of this research is to improve treatment outcomes for individuals with comorbid PTSD and alcohol abuse and dependence (AUD), comparing relapse prevention and cognitive processing therapies.Role: Co-Investigator 5 P60 MD006909-02 Walters (PI) 08/02/12 – 02/28/17 NIMHD Indigenous Wellness Research Institute National Center of Excellence Goals: To establish a national NIMHD Comprehensive Center of Excellence (P60), which aims to improve American Indian and Alaska Native (AIAN) health and eliminate health disparities by: (1) developing an integrated, comprehensive, and centralized trans-disciplinary research infrastructure that builds on the successes of the Indigenous Wellness Research Institute’s (IWRI) research, training activities, and community capacity building; (2) cultivating existing and establishing novel partnerships with AIAN tribal communities and

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other organizations to facilitate truly collaborative research; (3) developing new and enhancing existing research training activities at IWRI that prepare researchers to conduct scientifically rigorous and culturally grounded health research; and (4) strengthening and consolidating AIAN engagement, outreach and institutional partnerships. Role: Co-Investigator 5 R01 DA030351-02 Banta-Green (PI) 05/15/12 – 04/30/17NIDA A Trial to Prevent Opioid Overdose: E. D. Based Intervention & Take-home Naloxone The goals of this study are to determine the impact of an emergency department based intervention on opiate overdose risk behaviors and overdose occurrence. The intervention will include a brief behavioral change counseling session, opiate overdose education and prescribing of an opiate antidote for use in possible future opiate overdoses. A RCT of 500 heroin users and 500 pharmaceutical opiate users at risk for overdose will be conducted to test the intervention; subjects will be followed longitudinally via interviews and medical records. Role: Co-Investigator 1 R25 MH099132-01 Mathai (PI) 09/18/12 – 08/31/15 NIMH Linked – Mental Health Research Training for Improved Health Outcomes in Kenya This award aims to improve mental health research capacity by training University of Nairobi (UON) faculty and postgraduates and by establishing a Mental Health Resource Center to support these efforts at UON. Role: Key Personnel 5 R01 DA029001-04 Duran (PI) 09/30/09 – 08/31/13 NIDA CBPR with Tribal Colleges & Universities: Alcohol Problems/Solutions This project with Tribal Colleges and Universities: Alcohol, Drug and Mental Disorder Problems and Solutions Study (CBPR-TCU ADM PSS) will use Community-Based Participatory Research (CBPR) methods to conduct the first investigation of Alcohol, Drug and Mental Disorders (ADM) at Tribal Colleges and Universities (TCU) and is a preliminary step on a path toward developing culturally appropriate and sustainable interventions at TCU. Role: Investigator 5 T32AA007455-29 Larimer (PI) 07/01/84 – 06/30/14 NIAAA Psychology Training in Alcohol Research A program for post-doctoral fellows to train psychologists in social learning, clinical, and physiological aspects of the etiology and treatment of alcohol abuse and dependence. Role: Core faculty member Completed Research Support HHSN271201200014C Luchansky (PI) 08/20/12 – 05/19/13 NIDA The Drugged Driving Information Service This sub-contract proposal will support the development of a web based system to track drugged driving incidents in Washington State and a web based knowledge database for effective drugged driving interventions.Role: Co-Investigator OPP1038263 Thomas (PI) 07/01/11 – 01/31/13 Bill & Melinda Gates Foundation Washington Tribes and RAIO Health Priorities Summit The Summit will invite leaders from the 29 federally recognized Tribes and the 5 RAIOs in WA State for 1-1/2 days to identify and document health priorities/issues of greatest concern in the Tribal and AIAN communities and urban areas; promising practices in these communities; and gaps in health services and strategies for addressing these shortcomings. It will result in a report that prioritizes health needs, resources and gaps in order to make recommendations and guide policy with regards to the health of AIAN people in WA State. Role: Co-Investigator

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Appendix A

Instruments for Evaluation

Given the novelty of our proposal, there are few instruments available to evaluate health care professionals’ knowledge and attitudes on medical cannabis. For this project, we will consider two instruments utilized in recently published studies for adaptation to the specific needs of our target populations.

The first instrument assesses attitudes among physicians toward medical cannabis in Colorado and the second assesses knowledge, views and experiences among hospice health care providers. A more detailed description of these instruments and their references can be found below:

Physician Attitudes The instrument is a 3-part survey starting with demographic information (age, sex, and years in practice). The second part assesses respondents’ experience with medical marijuana, including whether they have ever recommended medical marijuana to a patient, how many times, and for which medical conditions; which factors most influenced their decision to recommend medical marijuana; and from which sources they obtained most of their information about medical marijuana. In the third part, respondents are asked to rate, on a 5-point Likert scale, the extent to which they agree or disagree with 17 statements about marijuana policy in Colorado and nationally (including legalization of marijuana for recreational use, reclassifying marijuana from schedule I, and distribution of medical marijuana through a dispensary model); the risks and benefits of marijuana use; and educational opportunities about marijuana at various levels of medical training.

Reference: Kondrad E, Reid A. Colorado family physicians' attitudes toward medical marijuana. J Am Board Fam Med. 2013 Jan-Feb;26(1):52-60. doi: 10.3122/jabfm.2013.01.120089.

Knowledge, views and experience This is a 16-item questionnaire, comprised of two open-ended questions soliciting participant's knowledge of potential medical uses and adverse effects of marijuana. A series of multiple choice questions query participants' experience and views regarding the use of marijuana to palliate symptoms.

Examples of the multiple choice questions are to rate symptoms improved by medical marijuana use among patients ( pain, mood, nausea/vomiting, anorexia/appetite) or to identify possible side effects associated with marijuana use (hunger, sedation, brain function, altered mental status, improved mood, etc.)

Reference: Tanya J. Uritsky, Mary Lynn McPherson, and Françoise Pradel. Assessment of Hospice Health Professionals' Knowledge, Views, and Experience with Medical Marijuana Journal of Palliative Medicine. December 2011, 14(12): 1291-1295. doi:10.1089/jpm.2011.0113.

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Appendix B Relevant Literature and Resources

1. Abrams DI, Couey P, Shade SB, et al. Cannabinoid-opioid interaction in chronic pain. Clin Pharmacol Ther 2011;90(6):844-51.

2. Aggarwal SK. Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results. Clin J Pain 2013;29(2):162-71.

3. Aggarwal SK, Carter G, Sullivan M, et al. Distress, coping, and drug law enforcement in a series of patients using medical cannabis. J Nerv Ment Dis 2013;201(4):292-303.

4. Aggarwal SK, Carter GT, Sullivan MD, et al. Characteristics of patients with chronic pain accessing treatment with medical cannabis in Washington state. J Opioid Manag 2009;5(5):257-86.

5. Banta-Green C, Brunner M. Opiate use and negative consequences in Washington State. (ADAI Info Brief) Seattle: UW Alcohol & Drug Abuse Institute, August 2011. URL: http://adai.uw.edu/pubs/infobriefs/ADAI-IB-2011-03.pdf

6. Carter GT, Flanagan AM, Earleywine M, et al. Cannabis in palliative medicine: improving care and reducing opioid-related morbidity. Am J Hosp Palliat Care 2011;28(5):297-303.

7. Carter GT, Abood ME, Aggarwal SK, Weiss MD. Cannabis and amyotrophic lateral sclerosis: hypothetical and practical applications, and a call for clinical trials. Am J Hosp Palliat Care 2010;27(5):347-56.

8. Carter GT, Ugalde V. Medical marijuana: emerging applications for the management of neurologic disorders. Phys Med Rehabil Clin N Am 2004;15(4):973-54.

9. Centers for Disease Control and Prevention (CDC). Overdose deaths involving prescription opioids among Medicaid enrollees – Washington, 2004-2007. MMWR Morb Mortal Wkly Rep 2009;58(42):1171-1175.

10. Charuvastra A, Friedmann PD, Stein MD. Physician attitudes regarding the prescription of medical marijuana. J Addict Dis 2005;24(3):87-93.

11. Irvine G. Rural doctors’ attitudes to and knowledge of medicinal cannabis. J Law Med 2006;14(1):135-42.

12. Johnson TP, Booth AL, Johnson P. Physician beliefs about substance misuse and its treatment: findings from a U.S. survey of primary care practitioners. Subst Use Misuse 2005;40(8):1071-84.

13. Kondrad E, Reid A. Colorado family physicians’ attitudes toward medical marijuana. J Am Board Fam Med 2013;26(1):52-60.

14. McCambridge J, Strang J, Platts S, Witton J. Cannabis use and the GP: brief motivational intervention increases clinical enquiry by GPs in a pilot study. Br J Gen Pract 2003;53(493):637-9.

15. Russo EB. Cannabinoids in the management of difficult to treat pain. Ther Clin Risk Manage 2008;4(1):245-259.

16. Russo EB. The solution to the medicinal cannabis problem. IN: Schatman ME (ed.). Ethical Issues in Chronic Pain Management. New York: Informa Healthcare, 2007, pp. 165-194.

17. Russo EB. The role of cannabis and cannabinoids in pain management. IN: Boswell MV, Cole BE (eds.). Pain Management: A Practical Guide for Clinicians (7th ed.). New York: Taylor & Francis, 2006, pp. 823-844.

18. Russo EB, Hohmann AG. Role of cannabinoids in pain management. IN: Deer TR et al (eds.). Comprehensive Treatment of Chronic Pain by Medical, Interventional, and Integrative Approaches. New York: Springer, 2013, pp. 181-197.

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19. Wilsey B, Marcotte T, Deutsch R, et al. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain 2013;14(2):136-148.

Educational Resources

Americans for Safe Access: http://safeaccessnow.org. Founded in 2002, ASA is the largest organization of patients, medical professionals, scientists, and concerned citizens promoting safe and legal access to cannabis. Web site features legal information, advocacy, online trainings, and a variety of medical and scientific information about cannabis. The site’s “Training Center” includes a collection of videos and online trainings to help inform patients, clinicians, and advocates about the history of medical cannabis, cannabidiol science (for doctors), resources for finding local legislation information, patient rights, testifying before civic bodies, public speaking, and more.

The Answer Page, co-sponsored by Harvard Medical School and the Massachusetts Medical Society, uses a “Question of the Day” teaching format for online trainings with CME. Users who register for the site read a daily set of 4-5 questions and answers based on a specific topic (such as “Pharmacology of Cannabis and Cannabinergic Medicines”) and then complete a weekly quiz based on the content. The site presents information in a brief, but frequent (daily), format to help keep users engaged and make CME accessible to physicians who are pressed for time. It has been recognized by the Accreditation Council for Continuing Medical Education (ACCME) as an example of particularly high-quality online education.

Canadian Consortium for the Investigation of Cannabis: http://www.ccic.net. The CCIC is a federally registered Canadian nonprofit organization of basic and clinical researchers and health care professionals interested in promoting evidence-based research and education about the endocannabinoid system and its therapeutic applications. Site includes educational elements, research, resources, symposia, networking forums, and more.

StopOverdose.org: http://stopoverdose.org. This site, developed and maintained by the Alcohol & Drug Abuse Institute at the University of Washington, provides information and online trainings about preventing and reversing opioid overdoses (including instructions on how to obtain and use naloxone).

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PROJECT BUDGET

Proposal Title

Principal Investigator Beatriz Carlini

Applicant Organization University of Washington

Applicant UW Department Alcohol and Drug Abuse Institute

Project start date

Project end date

Salaries/Benefits Base Salary Benefits Salary Benefits

Months Effort Salary Year 1 Year 1 Year 2 Year 2 Total

Beatriz Carlini, PI 18 0.25 86,520 21,630 7,354 11,139 3,787 43,911

Jennifer Velotta, Outreach Specialist 6 0.10 51,912 2,596 883 0 0 3,478

TBN, Project Coordinator 18 0.35 43,680 15,288 2,523 7,873 1,299 26,983

Roger Roffman, Collaborator 12 0.02 166,584 2,563 423 0 0 2,986

42,076 11,182 19,013 5,087 77,358

Goods and Services 22,144

Crisis Clinic 2,500

Washington Poison Center 2,500

Consultant, Gregory Carter 3,000

CME accreditation fee, 2 years 750

Printing, 5,000 brochures 2,745

Graphic Design Services 3,000

UW Webinar facilities 396

Software, Articulate 1,398

Office lease, PI and project coordinator 5,516

Phone, conference call number for advisory group 75

Phone, PI and project coordinator 263

Travel 770

Travel, local mileage, parking 770

Total UW Direct Costs 100,272

UW Administrative/Overhead 10% 10,027

Total UW Funding Request 110,299

March 31, 2015

October 1, 2013

Chronic Pain Management and Marijuana Use: Science-Based

Education in Times of Legalization