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By Rick Doblin, PhD, Executive Director 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 December 4, 2010. With Facts. Replacing Fears.

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By Rick Doblin, PhD, Executive Director Multidisciplinary Association for Psychedelic Studies

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  1. 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 • December 4, 2010

  2. With Facts Replacing Fears...

  3. “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.

  4. Brain SPECT Scan-MTV/OprahHoles in the Brain from MDMA?(Ecstasy. Create Fear.)

  5. Leshner Testimony to Senate Subcommittee on Government Affairs 7/30/01

  6. Bottle from experiement of MDMA Harvard MDMA Cancer - ask John

  7. Documentary Clip

  8. 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?

  9. 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

  10. 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

  11. 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)

  12. Why PTSD? PTSD MDMA A fear-based disorder Treatment for fear $300 million of existing research Millions of users, rare side effects known Top priority combination of psychedelic drug and clinical condition =

  13. 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

  14. Development of our Therapeutic Model Can be viewed at www.maps.org

  15. 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

  16. Cause of PTSD Related to Treatment Method? • Sexual assault vs. war-related trauma?

  17. Successful Double-Blinding • Inactive placebo • Active placebo • Dose response

  18. Treatment Effect (Variance & Magnitude) • Data from US versus Swiss • get Swiss data from Ilsa

  19. Cultural Differences

  20. 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

  21. O u t c o me F o l l o w U p 3 2 1 3 2 3 2 1 1 3 1 2 Screening/Baseline Exp Session Exp Session Exp Session Treatment Process Non-Drug Integrative Therapy Sessions Non-Drug Integrative Therapy Sessions • 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 90- Min Non-Drug Integrative Therapy Sessions 90-Minute Non-Drug Intro Therapy Sessions MDMA or Placebo MDMA or Placebo MDMA or Placebo

  22. get from ilsa orMM this yellow colum should be 25%

  23. US Long-Term Follow-Up

  24. 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

  25. graph of Swiss data

  26. 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

  27. Israel • 5 patients • No Serious Adverse Events (no evidence of harm) • No efficacy

  28. Current & Upcoming Studies • Canada • Israel • Jordan • US MDMA/PTSD War Veterans

  29. 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

  30. 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

  31. 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

  32. Arabic CAPS

  33. US: MDMA/PTSD Study inWar 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

  34. 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

  35. Zulfi July 21, 2010 Text

  36. 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

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