Transcript MDMA - Multidisciplinary Association for Psychedelic Studies

Developing Psychedelics into
Prescription Medicines:
MDMA-Assisted Psychotherapy for
Posttraumatic Stress Disorder
By Rick Doblin, PhD, Executive Director
Multidisciplinary Association for Psychedelic
Studies
Entheogenesis Australias
Replacing Fears...
With Facts
find of a drug lab they had raided and
taken a photo of.” -Dr. David E. Nichols,
Ph.D.
• “I love the way the way they always
throw the battery acid and drain cleaner
into the story, as if prescription drugs
were not manufactured using the exact
same reagents, which are simply dilute
sulfuric acid and sodium hydroxide!” -Dr.
Nicholas Vito Cozzi, Ph.D.
Brain SPECT ScanMTV/Oprah
Holes in the Brain from
MDMA?
(Ecstasy. Create Fear.)
Leshner Testimony to Senate
Subcommittee on Government Affairs
7/30/01
Bottle from experiement of MDMA
Harvard MDMA Cancer - ask John
Documentary Clip
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Outline
Why MDMA?
Why PTSD?
Questions for Phase II trials
US Pilot study & follow-up: Design &
Results
International series of Phase II studies
US MDMA/PTSD war veterans study
Australian MDMA/PTSD study?
Why MDMA?
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Reduces fear response to perceived
emotional threat (reduced activity in
amygdala; Gamma, A., et al., 2002)
Increases trust and empathy (oxytocin,
prolactin, similar to post-orgasmic state;
Passie et al., 2005)
Gentle but profound; easier to integrate
Therapists/psychiatrists more willing to
self-experiment than classic psychedelics
Why MDMA?
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Highly demonized: 3500+ papers in
Medline about risks/mechanisms of action
Estimated cost $300 million worth of
studies in the public domain
MAPS spent $150,000 to read and
summarize all published scientific peerreviewed literature on MDMA
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Why PTSD?
Current treatment approaches fail to
provide relief in a substantial number of
patients
Internationally accepted outcome measure
(CAPS)
Therapeutic change captured by outcome
measure (not the case with psychedelic
therapy for end-of-life anxiety &
depression)
Highly sympathetic patient population
(Veterans, survivors of sexual assault,
abuse, accidents, and trauma)
Why PTSD?
PTSD
A fear-based disorder
MDMA
Treatment for fear
$300 million of existing research
Millions of users, rare side effects known
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Top priority combination of
psychedelic drug and clinical
condition
Phase II
Methodological
• DevelopmentIssues
of our therapeutic model
• Training of therapists
• Cause of PTSD related to treatment
method?
• Successful double-blind design
• Variance and magnitude of treatment
effect
• Cultural differences
Development of our
Therapeutic Model
Can be viewed at www.maps.org
Therapists
• Training
5 day training program
mostly watching
videos and reviewing treatment manual
and adherence criteria
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Psychological effects of MDMA
administration in normal volunteers
training to conduct MDMA-assisted
psychotherapy research
• Review video tapes of first two therapy
sessions by raters scoring adherence
criteria with feedback from Mithoefers
Cause of PTSD
Related to Treatment
Method?
•Sexual assault vs. war-related trauma?
Successful
Double-Blinding
• Inactive placebo
• Active placebo
• Dose response
Treatment Effect
(Variance &
Magnitude)
• Data from US versus Swiss
• get Swiss data from Ilsa
Cultural Differences
US MDMA/PTSD
Pilot Study Design
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Treatment resistant/pharmacotherapy &
psychotherapy
Average duration PTSD = 19 years
Inactive placebo versus 125mg + 62.5mg
Combination: drug & non-drug
psychotherapy
2-3 MDMA sessions with 2 month & longterm follow-up
Treatment Process
Non-Drug
Integrative
Therapy
Sessions
Non-Drug
Integrative
Therapy
Sessions
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2
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90- Min Non-Drug
90-Minute Non-Drug
Integrative
Intro Therapy Sessions Therapy Sessions
Screenin
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Exp
Sessio
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MDMA or
Placebo
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Exp
Sessio
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MDMA or
Placebo
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Exp
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MDMA or
Placebo
In addition, therapists have up to a 30-minute phone session
with participant for 7 days following each experimental
session.
Outcome Assesment = 2 months after last experimental session
Follow-up Assessment = 12 months after last experimental session
get from ilsa orMM this yellow colum should be 25%
US Long-Term FollowUp
Swiss MDMA/PTSD
• Improvements not observed in active
placebo group 25mg + 12.5mg BUT did
produce some blinding
• MDMA group benefited, but not as much
as in
US MDMA/PTSD study
• No Serious Adverse Events (no
evidence of harm)
• Long-term follow-up to be completed
Jan 2011; paper submitted to journal by
April 2011
• graph of Swiss data
Swiss
• Physiological correlates of PTSD study
conducted by Dr Franz X. Vollenweider,
M.D. @ University of Zurich in all 12
participants
• EEG
• Startle reflex
• Heart rate variability (HRV)
• Results will be published as a separate
paper
Israel
• 5 patients
• No Serious Adverse Events (no
evidence of harm)
• No efficacy
Current & Upcoming
Studies
• Canada
• Israel
• Jordan
• US MDMA/PTSD War Veterans
Canada
• Can we replicate US results in a similar
cultural context with similarly trained
therapists?
• N = 12
• 125mg + 62.5mg versus 25mg + 12.5mg
• 3 sessions
• Waiting on import permit
Israel
• Different cultural context
• 2 sessions instead of 3
• N = 10
• 125 + 62.5 versus 25 + 12.5
• Traditional psychiatrists paired with
psychologists experienced with PTSD
or MDMA
Jordan
• Different cultural context
• How do we teach our method?
• N = 12 Iraqi refugees in Jordan
• 3 Sessions
• 125 + 62.5 experimental dose
• Using a 40mg +20mg low dose- another
attempt to work on double-blind
• Arabic caps on next slide
Arabic CAPS
US: MDMA/PTSD Study
in
War Veterans
• To see if cause of PTSD requires
different method
• Investigate double-blind: 3 dose groups:
Low (30 mg + 15mg), medium (75 mg +
37.5) and full dose (125 mg + 62.5)
• Higher risk populations (controlled
hypertension and Hepatitis C)
• Potential design for Phase III studies
Timeline
• 2-3 years to FDA End of Phase II Mtg
• 3-5 years for all Phase 3 studies
• 1-2 years for FDA review
Zulfi
July 21,
2010
Text
Australian
MDMA/PTSD
• 25k matching grants for Australia
MDMA/PTSD
• + Protocol devel and approval
assistance
• + therapist training
• + clinical research oversight
• email from someone who contacted rick
from Aus- Vets in Aus who wanted to
come participate in US study