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ATOP presentation
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Assessing the effectiveness of ayahuasca for the treatment of addictions: What is the “right”
research paradigm?
Dr. Brian RushProfessor
University of Toronto, Dept. of Psychiatry Scientist Emeritus,
Centre for Addiction and Mental HealthHealth Systems and Health Equity Research Group
Toronto, Canada
Canada and the importance of cultural context
Objectives Today
Situate today’s presentation in the current research literature on the treatment of addictions and therapeutic effectiveness of ayahuasca
Describe potential research paradigms that can be used to make further progress in this important area
Briefly describe the Ayahuasca Treatment Outcome Project (ATOP), it’s mixed model approach and next steps
The reality of addictions treatment on a global scale
Need in the community is much greater than our current capacity to respond – especially indigenous people - it truly is a global challenge and a very expensive one
The majority of people who need help do not seek help, even when good services are available (only about 20% or less)
Realities ….. Many people get better on their own but its not
ideal – a lot of people, families and communities get hurt along the way – we have a responsibility to help
Treatment DOES WORK but it usually takes several attempts and we need a lot more options – severe addiction is very difficult to resolve, especially in combination with major mental health challenges such as depression and trauma
Mental Disorders
Co-morbidity of Mental Health and Addiction Challenges in Treatment
Populations
Substance Use
Disorders70- 80%
Realities ….. Some common elements of treatment success
include: Therapeutic relationship and trust Tolerance and respect Belief and expectancies Culturally appropriate
To summarize: we have a moral and therapeutic imperative to continue searching for more treatment options that are appropriate for more people
The reality in many parts of North, Central and South America as well
as Australia and NZ
Justice
Street services
Schools
Social Assistance
Housing
Workplace
Traditional Healing
Why would we NOT want to study and learn from these traditions?
(moral and therapeutic imperative)
Hospitals
Addiction Services
Mental Health
Primary Care
Our Vision Traditional healing is recognized as a legitimate
part of the community treatment system – we must extend our services to where the people are at in their own cultural context
Treatment centres and professionals using traditional healing approaches need to be linked with larger system of services and not working in isolation - and they need to be recognized as partners in the network
The importance of “evidence” in going forward Research evidence plays an important role in gaining acceptance of other professionals, funders and the community as a whole
Research evidence plays an important role in being sure people are being treated safely and respectfully
Current challenge – there are many kinds of research and many ways of knowing something
What is the current evidence base (for addictions)?
Very strong cultural/community knowledge base within indigenous communities and the Brazilian churches
Studies of long-term users show very low toxicity, zero addiction potential and often better health on several indicators
Retrospective studies of long term users show strong evidence of recovery from alcohol and drug dependence
Prospective follow up studies have been limited in their design (Takiwasi, Canada) but results in the right direction
Qualitative research on subjective experience – reasons for use, personal benefits, assessment of therapeutic mechanisms
A continuum of “knowing” in relation to healing
The pyramid of current Evidence-Based Medicine (EBM)
Indigenous evaluation paradigm
Common territory being explored in ATOP
The “Evidence Pyramid” Behind Current Medical Practice
Meta-Analysis
Systematic Reviews
Randomized Control Trials
Cohort Studies
Case Control Studies
Case Reports
Animal Research
Adaptation of the “Evidence Pyramid” for Public Health
Practice Experimental Studies
(I-Low, II- Moderate, III-High)
Quasi- Experimental Studies
(I-Low, II- Moderate, III-High)
Analytic Observational Studies
(I-Low, II- Moderate, III-High)
Adaptation of the Pyramid For Qualitative Evidence
I - Generalizable conceptual studies
II- Descriptive Studies
III- Single Case Studies
(I-Low, II- Moderate, III-High)
But this is the Pyramid that Rules today for Modern Medicine
Meta-Analysis
Systematic Reviews
Randomized Control Trials
Cohort Studies
Case Control Studies
Case Reports
Animal Research
Evolving models of research evidence More recognition now for “practice-based
evidence as opposed to evidence-based practice
More recognition of ”community-defined,” culture-based evidence
More recognition of the limitations of RCT’s
Who is actually is in the studies? Does it really work for highly complex interventions?
So what about ayahuasca in all and its tremendous
complexity?
Banisteriopsis caaba
In what context is it used for healing? Indigenous Amazonian context (Peru, Equador,
Columbia, Venezuela.. some aspects remain in Brazil) – local healers/curanderos, shamanic practice – ritual, icaros, dietas, many variations
Neo-shamanic centres – some specific to addictions and/or mental health (Peru, Argentina) – many others for mental wellness and spiritual growth – various practices integrated
Syncretic churches in Brazil – used as a ceremonial sacrament - Santo Daime, UDV, Barqinha
Alternative healing contexts
Dimensions of the Complexity Cultural and community context (e.g., belief, values)
Production context (e.g., plant mix, training) Context of use (e.g., shamanic/church, curandero,
icaros, other plant mix, group/dieta, light/dark, etc.) Personal context (e.g., physical/mental health, diet,
abstinence, previous experience, intention,motivation) Neuro-biological context (e.g., absorption rate,
neuroplasticity, serotonin uptake) Energetic context (e.g., invasion/bad intention, darts,
location)
The purpose of an experimental design is to REMOVE all of this context and isolate the “active ingredient” of interest to the researcher
If we really think about this what are the chances of success? Is it really appropriate to try?
What is the current evidence base (for addictions)?
Very strong cultural/community knowledge base within indigenous communities and the Brazilian churches
Studies of long-term users show very low toxicity, zero addiction potential and often better health on several indicators
Retrospective studies of long term users show strong evidence of recovery from alcohol and drug dependence
Prospective follow up studies have been limited in their design (Takiwasi, Canada) but results in the right direction
Qualitative research on subjective experience – reasons for use, personal benefits, assessment of therapeutic mechanisms
Do we need to do more?
Part of the Globalization of Ayahuasca What are “safe” practices?
What practices can be better informed by evidence (however that is interpreted)?
What can these practices (plant medicines) teach us about healing and therapeutics?
What traditional and “modern” practices can be combined to benefit people seeking help?
What can the study of traditional medicine teach us about “evidence-based medicine”?
An Indigenous Evaluation Paradigm All things are living, spiritual entities and relational –
including knowledge itself as such has moral purpose) -what is the good to come nothing can be isolated from its context – all views are
wholistic Knowledge has meaning only in a place/community
context and through direct experience Outcomes (and risks) relate to family/community Evaluator must have relationship with program
representatives
Key principles of indigenous evaluation practice (con’t) Meaningful involvement Respect for culture in defining questions and
gathering information Using metaphor and stories to guide the
evaluation process Capacity building Interpretation in indigenous context/cosmology Sharing of results respectfully and with
premission
Reconciling these Research Paradigms
Reconciling these Research Paradigms
Realist Evaluation ModelComplexity-rich
Intervention + context = outcome Indigenous engagement Realist research synthesis and contribution
analysis Mixed methods: qualitative and quantitative Assess effectiveness in naturalistic settings (not
assessing efficacy in tightly controlled conditions)
What is ATOP? Ayahuasca Treatment Outcome
Project
ATOP Umbrella - Core team members -Project sites/partners:
• ATOP-Peru• ATOP-Mexico• ATOP- Brazil• Argentina/Uruguay - early stages
- consensus on core features
Under the ATOP umbrella: Core focus and objectives (e.g. addictions
and related co-morbidity) Core design
integration of traditional practices and modern therapeutics
inclusion/exclusion criteria baseline and at least one year follow up comparison/control conditions as local situation
allows
Under the umbrella…. Core descriptive, process and modifying
measures Demographics Diagnostic profile Wellness- Severity profile Previous healing/treatment experiences Family history Expectancies/beliefs Level of participation Motivation (level and source)
Under the umbrella…
Core outcome measures Substance use (ASI) plus substance use
measures from the GAIN Mental health (Beck depression/anxiety) Quality of life (WHO) Spirituality (WHO) Satisfaction with services (CSQ-8)
Under the Umbrella...
Core ethical principles (e.g., consents, locator processes for follow up, training/credentials of the curanderos, use of other plant medicines such as tobacco)
Core interest in the neuroscience aspects but questions and protocol yet to be defined and as local conditions allow
Staged approach to implementation… Start up funding by crowdfunding, DEVIDA in Peru, and other donations for initial planning meeting in Tarapoto Peru – umbrella defined
Current status of ATOP sub-projects ATOP-Peru – Funding application to Canada Grand
Challenges (meeting was yesterday!!) - decision announced in May
Letter of support from DEVIDA– national anti-drug agency Takiwasi, and several other Peruvian centres have committed
to join Independent third party follow up team Two-year time frame – may need additional resources to extend
the follow-up to one year post discharge
ATOP - Mexico – ask Anja best way to say ATOP - Brazil (proposal under development for SENAD)
Takiwasi
ATOP-Mexico Controlled randomized study – ayahuasca-
assisted psychotherapy following detox Control conditions – placebo or retreat
without ayahuasca 18-month follow-up ATOP baseline and outcome measures Proposal is under review
ATOP-Brazil Proposal under development for submission
to SENAD – Brazilian gov’t anti-drug agency Three potential centres identified at this point Common measures –some challenges with
infrastructure to be overcome but Additional cross-sectional descriptive
component – nation-wide Anticipated submission date: fall of 2014
What is ATOP? Ayahuasca Treatment Outcome
Project ATOP Umbrella - consensus on core features-Core team members -Project sites/partners:
ATOP-PeruATOP-MexicoATOP- BrazilArgentina/Uruguay - early stages
- Advisory structure – curanderos, leaders
Reconciling these Research Paradigms
Reconciling these Research Paradigms
Reconciling these Research Paradigms
Muchas gracias y buena suerte en su trabajo personal y
profesional!!!
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