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Developing Psychedelics into Prescription Medicines:
MDMA-Assisted Psychotherapy for Posttraumatic Stress
DisorderBy Rick Doblin, PhD, Executive Director
Multidisciplinary Association for Psychedelic Studies
Entheogenesis Australias December 4, 2010
Replacing Fears... With Facts
•“Probably the worst example they could 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 Scan-MTV/Oprah
Holes in the Brain from MDMA?
(Ecstasy. Create Fear.)
Leshner Testimony to Senate Leshner Testimony to Senate Subcommittee on Government Subcommittee on Government
Affairs 7/30/01Affairs 7/30/01
Bottle from experiement of MDMA
Harvard MDMA Cancer - ask John
Documentary Clip
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?•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?
•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 peer-reviewed literature on MDMA
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 disorderMDMA
Treatment for fear
$300 million of existing research
Millions of users, rare side effects known
Top priority combination of psychedelic drug and clinical
condition
=
Phase II Methodological
Issues •Development 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
Training Therapists •5 day training program mostly watching
videos and reviewing treatment manual and adherence criteria
•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•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 & long-term follow-up
Treatment Process
• 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
ScreeninScreening/g/
BaselineBaseline
90-Minute Non-Drug 90-Minute Non-Drug Intro Therapy SessionsIntro Therapy Sessions
11 22 33
MDMA or Placebo
11
22
33
90- Min Non-Drug Integrative
Therapy Sessions
Exp Exp SessionSession
11
22
33Exp Exp
SessionSessionExp Exp
SessionSession
11
22
33
MDMA or Placebo
MDMA or Placebo
Non-Drug IntegrativeTherapy Sessions
Non-Drug IntegrativeTherapy Sessions
OOuuttccoommee
FFoollllooww
UUpp
get from ilsa orMM this yellow colum should be 25%
US Long-Term Follow-Up
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
Text
July 21, 2010
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