Scientific Freedom for Psychedelic and Marijuana Research Rick - - PowerPoint PPT Presentation
Scientific Freedom for Psychedelic and Marijuana Research Rick Doblin, Ph.D. Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS) World Congress for Scientific Freedom European Parliament Brussels,
Rick Doblin, Ph.D. Founder and Executive Director, Multidisciplinary Association for Psychedelic Studies (MAPS)
World Congress for Scientific Freedom European Parliament Brussels, Belgium April 13, 2018
First pre-clinical pharmacological tests with MDMA by Merck, nothing interesting found.
Alexander “Sasha” Shulgin
MDMA used in psychotherapy with good results. Estimated 500,000 doses
settings from mid-1970s until 1984. Reported to increase communication, and found to be especially useful for couples therapy.
Leo Zeff
By the early 1980s, "ecstasy" (MDMA + other psychoactive substances) became a popular drug often at dance clubs and raves in the US and Europe.
The Drug Enforcement Administration (DEA) moves to classified MDMA as a Schedule 1 controlled substance. Advocates file for Administrative Law Judge (ALJ) hearing within 30 day public comment period.
The Drug Enforcement Administration (DEA) classified MDMA as a Schedule 1 controlled substance using emergency scheduling authority, later declared invalid.
1986
The Multidisciplinary Association for Psychedelic Studies (MAPS) is founded April 8, 1986.
FDA approves first Phase 1 dose response safety study for MDMA in humans.
Sponsored by MAPS, the first randomized, placebo-controlled, double-blind study investigating MDMA-assisted therapy, conducted in women with treatment-resistant PTSD, commenced in 2000 in Spain but ended due to political pressures after only 6 women were treated.
Out of desperation, MAPS called Copernicus Group IRB based on their name. Copernicus Group IRB approves the first MAPS-sponsored MDMA/PTSD protocol.
Pilot MDMA/PTSD study is published.
Mithoefer et al. (2010). J. Psychopharmacology
Long term follow up paper is published.
Mithoefer et al. (2012). J. Psychopharmacology
Expansion of neuroscience research with psychedelics and MDMA. “The world’s populations need more compassion and empathy for one another. The study of MDMA provides one small but potentially important step toward reaching that goal.”
Boris D. Heifets & Robert C. Malenka Stanford University School of Medicine Cell, Vol. 166, Issue 2 July 14, 2016
Photo by Nirvan Mullick, PrescriptionX – The Rick Doblin Story
MAPS completes international series of six Phase 2 pilot studies of MDMA-assisted psychotherapy for PTSD. Nov 29, 2016 Successful End of Phase 2 Meeting with FDA.
Study Location Intent to Treat Sample MP1 Charleston, SC 23 MP2 Switzerland 14 MP4 Vancouver, Canada 6 MP8 Charleston, SC 26 MP9 Israel 10 MP12 Boulder, CO 28 Total 107
N=31 N=90
Unpublished Data
N=100 (N=77 had 3 sessions)
2-Month Follow-up Screen & Enroll 80 or 120 mg 80 or 120 mg 80 mg Inactive Placebo Inactive Placebo Inactive Placebo 3 Prep Sessions 9 Integrative Psychotherapy Sessions 3 Prep Sessions 9 Integrative Psychotherapy Sessions
2017
FDA grants Breakthrough Therapy Designation for MDMA-assisted psychotherapy for PTSD. Large scale studies planned to begin enrollment in Spring 2018.
First Breakthrough Planning Meeting with the FDA Department of Psychiatry Products. Discussed submitted questions regarding program requirements for approval.
First meeting with European Medicines Agency (EMA) to begin negotiations for approval in Europe. Scientific Advice Briefing Document for Phase 3 MDMA/PTSD clinical trials in Europe submitted to EMA.
therapists trained by the sponsor.
clinics.
specified patient populations.
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch/Waxman Amendments)
September 24, 1984
“Under FDA’s statute, a sponsor or a physician may submit an expanded access request for widespread access to an investigational product if certain criteria are met”
Potential Indications:
“Sec. 101. The Congress makes the following findings and declarations: (1) Many of the drugs included within this title have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.” “Sec. 201 (b). The recommendations [about scheduling] of the Secretary [of HHS] to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters.”
The purpose of this law is to expedite scheduling of newly approved drugs that are currently in Schedule I or not controlled. Requires DEA to initiate a scheduling action for new FDA-approved drugs within 90 days.
Funded by a $2.15 million grant to MAPS from the Colorado Department of Public Health and Environment
Attorney General Jeff Sessions President Donald Trump
With MAPS’ support, Professor Lyle Craker applied for a DEA license in 2001 and 2017