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Mdma Clinical Trials


A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder


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

Id: NCT04714359

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Not yet recruiting

Start Date: March 2021

Last Update: March 26, 2021

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit 16. This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

Conditions:
  • PTSD


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