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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: | NCT00090064 |
This study is being conducted to find out if methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is safe and can help people with posttraumatic stress disorder (PTSD) arising from being a victim of a crime.
Condition | Intervention | Phase |
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Posttraumatic Stress Disorder |
Drug: 3,4-methylenedioxymethamphetamine (MDMA) Drug: lactose (placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive 125 mg MDMA followed 2 to 2.5 hours later by 62.5 mg MDMA during course of each of two day-long psychotherapy sessions plus a third open-label MDMA-assisted session.
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Drug: 3,4-methylenedioxymethamphetamine (MDMA)
125 mg and 62.5 mg MDMA
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2: Placebo Comparator
Participants will receive an initial dose of placebo orally followed 2 to 2.5 hours later by a second dose of placebo during the course of each of two experimental sessions.
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Drug: lactose (placebo
two capsules placebo matched in weight with MDMA capsules
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, South Carolina | |
Offices of Michael Mithoefer MD | |
Mt. Pleasant, South Carolina, United States, 29464 |
Principal Investigator: | Michael Mithoefer, MD | Private practice |
Responsible Party: | Multidisciplinary Association for Psychedelic Studies (MAPS) ( Rick Doblin, PhD ) |
Study ID Numbers: | 63,384 |
Study First Received: | August 24, 2004 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00090064 |
Health Authority: | United States: Food and Drug Administration |
MDMA Methylenedioxymethamphetamine PTSD psychotherapy |
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 |