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, Belgium April 13, 2018
A Brief History of MDMA 1912-2018
1912 MDMA first synthesized and patented by the pharmaceutical company Merck as “Methylsafrylamin.” It was an unimportant precursor in a new synthesis for clotting agents.
First pre-clinical pharmacological tests with 1927 MDMA by Merck, nothing interesting found.
1953-1954 The United States Army used animal models to investigate the toxicity and behavioral effects of MDMA and seven other related compounds, but the results remained classified until 1973.
1959 Merck conducts further animal studies, nothing interesting found.
Mid-1970s An American chemist, Alexander “Sasha” Shulgin resynthesized MDMA and experimented with the drug himself. Alexander “Sasha” Shulgin
Late-1970s MDMA used in psychotherapy with good results. Estimated 500,000 doses of MDMA used in therapeutic growth settings from mid-1970s until 1984. Reported to increase communication, and found to be especially useful for couples therapy. Leo Zeff
1980-1984 By the early 1980s, "ecstasy" (MDMA + other psychoactive substances) became a popular drug often at dance clubs and raves in the US and Europe.
1984 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.
1985 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 1986 (MAPS) is founded April 8, 1986.
1986-1992 FDA rejects five different Phase 1 or Phase 2 protocols for MDMA clinical trials.
1992 FDA approves first Phase 1 dose response safety study for MDMA in humans. Dr. Charles Grob
2000 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.
2000-2004 Seven IRBs reject or refuse to review MAPS’ first FDA-approved MDMA/PTSD protocol.
Out of desperation, MAPS called Copernicus Group IRB based on their name. 2004 Copernicus Group IRB approves the first MAPS-sponsored MDMA/PTSD protocol.
2010 2012 Pilot MDMA/PTSD study is published. Long term follow up paper is published. Mithoefer et al. (2010). J. Psychopharmacology 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. 2016 Nov 29, 2016 Successful End of Phase 2 Meeting with FDA.
MAPS Sponsored Phase 2 Clinical Trials for MDMA-Assisted Psychotherapy for Chronic, Treatment-Resistant PTSD Intent to Treat Study Location Sample MP1 Charleston, SC 23 MP2 Switzerland 14 Vancouver, MP4 6 Canada MP8 Charleston, SC 26 MP9 Israel 10 MP12 Boulder, CO 28 Total 107
N=31 N=90 N=100 (N=77 had 3 sessions) Unpublished Data
July 28, 2017 FDA and MAPS reach agreement regarding the Phase 3 protocol designs through the Special Protocol Assessment process.
FDA Phase 3 Study Design: MDMA-Assisted Psychotherapy for PTSD 3 Prep Sessions 9 Integrative Psychotherapy Sessions 80 mg 80 or 120 mg 80 or 120 mg Screen 2-Month & Enroll Follow-up Inactive Inactive Inactive Placebo Placebo Placebo 9 Integrative Psychotherapy Sessions 3 Prep Sessions
2017 FDA grants Breakthrough Therapy Designation for August 15, 2017 MDMA-assisted psychotherapy for PTSD. Large scale studies planned to begin enrollment in Spring 2018.
December 19, 2017 DEA meeting to discuss increase in Schedule 1 licenses needed for Phase 3 and Expanded Access programs.
December 20, 2017 First Breakthrough Planning Meeting with the FDA Department of Psychiatry Products. Discussed submitted questions regarding program requirements for approval.
March 1, 2018 April 4, 2018 First meeting with European Scientific Advice Briefing Document Medicines Agency (EMA) to begin for Phase 3 MDMA/PTSD clinical trials negotiations for approval in Europe. in Europe submitted to EMA.
To be continued …
FDA Phase 3 Site Locations • San Francisco, CA | research institution • Farmington, CT | research institution • New York, NY | research institution • Madison, WI | research institution • Vancouver, Canada | research institution • Israel | research institution • San Francisco, CA | private practice • Los Angeles, CA | private practice • Boulder, CO | private practice • Fort Collins, CO | private practice • New Orleans, LA | private practice • New York, NY | private practice • Charleston, SC | private practice • Boston, MA | private practice • Montreal, Canada | private practice
Potential European Phase 3 Site Locations • Prague, Czech Republic • Utrecht, Netherlands • Amsterdam, Netherlands • Berlin, Germany • Hanover, Germany • Bristol, England • Cardiff, England • Others?
Potential Post Approval Risk Mitigation Strategies • Only prescribed by certified therapists trained by the sponsor. • Only administered in certified clinics. • Defined safety screening for specified patient populations.
Data Exclusivity Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch/Waxman Amendments) September 24, 1984
Expanded Access, Compassionate Use “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”
Off-Label Prescription Use Post-Approval Potential Indications: • Anxiety • Depression • Social Anxiety • Eating Disorders • Substance Use Disorder • Schizophrenia • Dissociative Identity Disorder
US Controlled Substance Act (1970) “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.”
US Improving Regulatory Transparency for New Medical Therapies Act (2015) 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 Safety and Efficacy of Marijuana for Treatment of Posttraumatic Stress Disorder (PTSD) in 76 US Veterans
“To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States.”
Return to Law and Order & Drug War Escalation President Donald Trump Attorney General Jeff Sessions
Scientific Freedom: Ending the NIDA Monopoly on DEA Licensed Marijuana With MAPS’ support, Professor Lyle Craker applied for a DEA license in 2001 and 2017
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