ATOP presentation

1. Assessing the effectiveness of ayahuasca
for the treatment of addictions: What is the
“right” research paradigm?
Dr. Brian Rush
Professor
University of Toronto, Dept. of Psychiatry
Scientist Emeritus,
Centre for Addiction and Mental Health
Health Systems and Health Equity Research Group
Toronto, Canada

7. Canada and the importance of
cultural context

8. 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

9. 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)

10. 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

11. Mental
Disorders
Co-morbidity of Mental Health and
Addiction Challenges in Treatment
Populations
Substance
Use
Disorders
70- 80%

12. 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

13. 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

15. 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

16. 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

17. 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

18. 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

19. The “Evidence Pyramid” Behind Current
Medical Practice
Meta-Analysis
Systematic Reviews
Randomized Control Trials
Cohort Studies
Case Control Studies
Case Reports
Animal Research

20. 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)

21. Adaptation of the Pyramid For
Qualitative Evidence
I - Generalizable
conceptual studies
II- Descriptive Studies
III- Single Case Studies
(I-Low, II- Moderate, III-High)

22. 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

23. 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?

24. So what about ayahuasca in all and
its tremendous complexity?

25. Banisteriopsis caaba

26. 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

27. Alternative healing contexts

28. 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)

29. 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?

30. 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

31. Do we need to do more?

32. 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”?

33. 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

34. 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

35. Reconciling these Research Paradigms

36. Reconciling these Research Paradigms

37. Realist Evaluation Model
Complexity-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)

38. 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

39. 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

40. 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)

41. 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)

42. 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

43. Staged approach to implementation…
 Start up funding by crowdfunding, DEVIDA in
Peru, and other donations for initial planning
meeting in Tarapoto Peru – umbrella defined

44. 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

45. Takiwasi

46. 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

47. 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

48. What is ATOP?
Ayahuasca Treatment Outcome Project
ATOP Umbrella
- consensus on core features
-Core team members
-Project sites/partners:
ATOP-Peru
ATOP-Mexico
ATOP- Brazil
Argentina/Uruguay - early stages
- Advisory structure – curanderos, leaders

49. Reconciling these Research Paradigms

50. Reconciling these Research Paradigms

51. Reconciling these Research Paradigms

52. Muchas gracias y buena suerte en su
trabajo personal y profesional!!!