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Sponsored by: |
Multidisciplinary Association for Psychedelic Studies |
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Information provided by: | Multidisciplinary Association for Psychedelic Studies |
ClinicalTrials.gov Identifier: | NCT00402298 |
This is a study of the safety and efficacy of MDMA-assisted psychotherapy in people with war or terrorism-related posttraumatic stress disorder (PTSD).
Condition | Intervention | Phase |
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Posttraumatic Stress Disorder |
Drug: 3,4-methylenedioxymethemphetmaine (MDMA_ Drug: 3,4-methylenedioxymethamphetamine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | MDMA-Assisted Psychotherapy in Twelve People With War and Terrorism-Related Posttraumatic Stress Disorder (PTSD) |
Estimated Enrollment: | 12 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive an initial dose of 125 mg MDMNA followed 2.5 hours later by a supplemental dose of 62.5 mg MDMA during the course of two day-long psychotherapy sessions.
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Drug: 3,4-methylenedioxymethemphetmaine (MDMA_
Participants will receive an initial dose of 125 mg MDMA orally followed 2.5 hours later by 62.5 mg MDMA orally during the course of a day-long psychotherapy session.
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2: Active Comparator
25 and 12.5 mg MDMA
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Drug: 3,4-methylenedioxymethamphetamine
Participants will receive an initial dose of 25 mg MDMA orally followed 2.5 hours alter by a supplemental dose of 12.5 mg MDMA orally during the course of each of two day-long psychotherapy sessions.
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Posttraumatic stress disorder (PTSD) occurs after experiencing a traumatic event or events. PTSD is a public health problem that causes a great deal of suffering. This study will examine whether two six to eight-hour long sessions of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy scheduled three to five weeks apart are safe, and whether combining a fully therapeutic dose of MDMA with psychotherapy, compared with a low ("active placebo") dose of MDMA, will reduce PTSD symptoms, with symptoms measured four times, twice during the study, and during two follow-up assessments six and twelve months after the second experimental session. People who received the active placebo dose of MDMA can then take part in an "open label" study continuation, with the participant receiving a fully active dose of MDMA on two more six to eight hour-long psychotherapy sessions. Open-label means that the participants and the researchers know that the participant will receive the fully active dose of MDMA. People who receive the full dose of MDMA, and anyone who received low-dose MDMA and does not undergo the open-label study continuation will have PTSD symptoms measured six and twelve months after the second fully active or low dose MDMA session. People who take part in the open label study continuation have their PTSD symptoms checked six and 12 months after the second open label MDMA-assisted session.
MDMA is a substance that has unique effects that make it well suited to intensive psychotherapy. MDMA may belong to a new class of drugs, called entactogens, that produce feelings of closeness to others, empathy, well being, and insightfulness. Currently, MDMA is scheduled in the US and Israel, and doctors and therapists cannot give it to people outside of research studies like this one. Anecdotal reports of therapy conducted before MDMA was made illegal suggest that MDMA-assisted psychotherapy may benefit people with PTSD, and there is an ongoing placebo-controlled study of MDMA-assisted psychotherapy in people with crime or war-related PTSD occurring in the US.
This study will look at MDMA-assisted psychotherapy in 12 individuals aged 18 years or older diagnosed with PTSD that arose out of war or terrorism-related trauma, with PTSD symptoms not improving after trying at least one treatment. Eight of 12 participants will be assigned to receive the full dose of MDMA, and four will be assigned to receive a low or "active placebo" dose of MDMA during each of two experimental sessions. People will be assigned to full or low-dose MDMA "by chance," as by flipping a coin. The fully active dose consists of an initial dose of 125 mg MDMA and a supplemental dose of 62.5 mg given 2 to 2.5 hours later. The active placebo dose consists of an initial dose of 25 mg MDMA and a supplemental dose of 12.5 mg.
The study will last approximately four months, and will include two sixty minute long introductory psychotherapy sessions, two active placebo or fully active dose MDMA-assisted psychotherapy sessions, a sixty to ninety minute long psychotherapy session 24 hours after each experimental session, and one to two hour-long psychotherapy sessions occurring weekly between the first and second experimental session, and between the second experimental session and the end of the study.
PTSD symptoms will be measured at the start of the study and eight weeks (two months) after the second experimental session. PTSD symptoms are assessed six and twelve months after the second experimental session in people who do not take part in the open-label study continuation. People who take part in the open-label study continuation will have their PTSD symptoms measured six and twelve months after the second MDMA-assisted psychotherapy session.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sergio Marchevsky, MD | bymarchevsky@beer-ness.health.gov.il |
Israel | |
Beer Yaakov Mental Health Center | Recruiting |
Beer Yaakov, Israel | |
Contact: Moshe Kotler, MD kotler@beer-ness.health.gov.il | |
Principal Investigator: Moshe Kotler, MD | |
Sub-Investigator: Sergio Marchevsky, MD |
Principal Investigator: | Moshe Kotler | Director of Psychiatry, Beer Yaakov Mental Health Center and Chair, Dept of Psychiatry, Tel Aviv University |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies ( Rick Doblin Ph.D., president ) |
Study ID Numbers: | M-P3 |
Study First Received: | November 20, 2006 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00402298 |
Health Authority: | Israel: Ministry of Health |
PTSD MDMA psychotherapy Posttraumatic stress disorder Israel |
Anxiety Disorders N-Methyl-3,4-methylenedioxyamphetamine Mental Disorders Stress Disorders, Post-Traumatic |
Stress Serotonin Stress Disorders, Traumatic |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs |
Psychotropic Drugs Hallucinogens Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Central Nervous System Agents |