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Mdma Clinical Trials


A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada


To see complete record on clinicaltrials.gov, please visit this link

Id: NCT01958593

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: September 2013

Last Update: December 11, 2017

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This small ("pilot") study is designed to provide information on whether the combination of psychotherapy with the drug MDMA is safe and helpful for people with post traumatic stress disorder (PTSD). The researchers will use the results of this study to design more studies of this treatment. The study compares a comparator (placebo) and a full dose. For each session, there will be an initial dose possibly followed 1.5 to 2.5 hours later by a dose half the size of the initial dose. The study will measure symptoms of PTSD, depression, general psychological well-being, sleep quality, feelings that the self or world is unreal (dissociation), potentially positive effects of surviving traumatic events and cognitive function (thinking, memory and attention). People experiencing pain or tinnitus (ringing in the ears) will record their symptoms throughout the study. Seven people will be randomly (by chance) assigned to receive full-dose MDMA and five will be randomly assigned to receive a comparator. There will be three preparatory psychotherapy sessions before the first experimental session, and subjects will have supportive or "integrative" sessions after each MDMA-assisted psychotherapy session. Subjects will meet with a male and female psychotherapist for all experimental sessions and for sessions before and after each experimental session. Subjects who received comparator can enroll in Stage 2, where they will have three open-label MDMA-assisted psychotherapy sessions, meaning everyone will know they are receiving an active dose of MDMA. Subjects receiving full dose in Stage 1 will have a third experimental session.. Symptoms of PTSD and other symptoms will be measured again at least 12 months after each subject has started the study.

Conditions:
  • Posttraumatic Stress Disorder


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