Kenton Crowley, PharmD, ABAAHP, FAARFM, FMNM

CMO, Palliative Care Corp, Huntington Beach, CADirector of R&D, Silver State Trading, Sparks, NV

President, Crowley Consultants Inc., Temecula, CAdrkent@pccorp.org

Guillermo Moreno-Sanz,PhDAssistant Project Scientist. Department of Anatomy &

Neurobiology. University of California, Irvine, CA

Scientific advisor at Pascal Labs, CA.

Impact of Standardized Cannabis Therapy in

Chronic Noncancer Pain with or without Opiate Use

CannMed 2017

Kenton Crowley PharmD & Guillermo Moreno-Sanz PhD

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THE OPIOID EPIDEMIC� US Prescription opioid-related deaths are increasing

while the number of prescriptions are decreasing

� 1/3 of US population reports chronic pain (100 mil)

� Letter from the Surgeon General to all colleagues� The fifth vital sign = Pain; poorly managed in the past� Two decades of aggressively treating pain with opioids

� As many as 1 in 4 on prescription opiate treatment for CNCP struggle with addiction

Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain —United States, 2016. MMWR RecomRep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1

Von Korff M, et al. United States National Pain Strategy for Population Research. J Pain 2016. doi: 10.1016/j.pain.2016.06.009.

BACKGROUND� Opiate access is becoming more limited (Opiate Crisis)

� The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (http://www.nap.edu/24625)

� Pain patients are seeking alternatives to opiate therapy to deal with chronic pain.

� Pain: #1 reported indication for cannabis use

� Cannabis is now a viable option in States with legal access

SCOPE OF RESEARCH� Report on the impact of standardized cannabis

formulations on patients with a diagnosis of chronic noncancer pain (CNCP), with or without concomitant use of opiates

� Report any adverse reactions observed with the incorporation of cannabis in patients pain management treatment

� Report patients opinion on overall quality of life change with the use of cannabis

EXPERIMENTAL APPROACH� Observational, longitudinal study design

� December 2016 end point

� 12 week treatment period prior to endpoint� Treatment periods of 7-30 days, 31-60 days, >60 days

� Document use of opiates or not for pain management

� Numeric analog scale (0-10), pre and post treatment

� Use of a global rating scale (same, better, worse)

INCLUSION CRITERIA� Diagnosis of chronic noncancer pain (CNCP)

� Willingness to use cannabis in addition to their current pain management treatment regimen

� Possess a valid medical recommendation for cannabis

� Use standardized cannabis dosage forms following a medication protocol developed at the clinic to optimize drug delivery and minimize possible adverse reactions in cannabis naïve patients

EXCLUSION CRITERIA

� Having a diagnosis of cancer

� History of an allergy to cannabis� Rx Drugs (Dronabinol, Nabilone, Nabiximols)

� Cardiac arrhythmia (any type, treated or not)

� Pregnancy

PATIENT POPULATION

� 81 patients with diagnosis of CNCP (70% women)� Mean age 62 (range 31 to 90)

� 21 were not evaluable� 12 were not active patients at time of data collection

� 9 were new to the program

� 59 remaining patients� 18 active and placing orders but no data points available

� 42 patients were left with data points evaluable and included in results

PATIENT POPULATION

� n=42� 15 male

� 27 female

� Average age 61.7 (range: 37 to 90)

� 35.7% (n=15) no opiates

� 64.3% (n=27) on opiates

� NAS pretreatment 7.2 (range: 4/10 to 10/10)

TREATMENT PROTOCOL� Trokie® dosage forms used during study period:

� 50mg CBD (European, organic, non-GMO, hemp)� 40mg 1:1 (20mg CBD: 20mg THC)� 64mg hybrid (1:15 ratio CBD:THC)� 120mg hybrid (1:15 ratio CBD:THC)� 120mg Indica (THCd9)

� Oral capsules of THCA-A & THC� 10mg Capsule (7:3 THCA-A/THC)� 30mg Capsule (7:3 THCA-A/THC)

� Others� 65% THC extract used in vaporizing device

Trokie Example

TREATMENT PROTOCOL� Trokie®, a patent pending buccal delivery system

using the following doses to start all patients:� CBD 12.5mg BID-TID to start x 3 days, then add� 10mg (1:1 CBD/THC) at bedtime (if wanted)

� Following initial dosing, adjustments were made based on patients response, tolerance to the psychoactive effects of THC (neutral form), preferred route of administration, and requests for dosage increases to meet participants desired pain management goals.

RESULTS� Average drop in NAS pain score of 4.9

� From 7.2 pre-treatment to 2.3 post-treatment (range 0/10 to 7/10)

� Represents a 68% improvement of NAS pain score

� Improvement varied slightly with duration of Tx� 66% reduction in NAS for 7-30 days

� 64% reduction in NAS for 31-60 days� 69% reduction in NAS for >60 days

� Global Rating scale: Overall Client feels (Better, Same, Worse): 100% reported feeling better

RESULTS� For patients on opiates (n=27)

� 14.8% (n=4) no change in opiate dose� 22.2%(n=6) reduction of opiate dose up to 25%� 25.9% (n=7) reduction of opiate dose up to 50%� 14.8% (n=4) reduction of opiate dose up to 90%� 22.2% (n=6) discontinued opiate entirely

� One participant used only CBD to DC opiate

� These reductions were done by the patients with no reports of symptoms of opiate withdrawal

� 85.2% of patients using opiates reduced or discontinued their use of opioid medication

RESULTS� No statistically significant difference in length of

treatment to reduction of NAS in all three treatment time periods

� No adverse events reported that caused discontinuation of cannabis therapy

� 9 participants used only CBD (no THC)� 4 not on opiates

� 5 on opiates, one discontinued opiate

� 9 participants used only caps (didn’t like Trokie® taste)

� 2 participants used vaping in addition to Trokie®

CONCLUSION� In an observational, longitudinal study, the use of

cannabis to treat chronic noncancer pain with or without opiates improved NAS pain scores in all participants

� Use of cannabis in pain management demonstrates as much as a 100% reduction in concomitant opiate use

� Use of cannabis did not present any adverse events that caused discontinuance of its use

� All participants noted a global improvement in their quality of life with the use of cannabis