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!!!