Mdma molecule:

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Mdma Clinical Trials

A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder

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Id: NCT03537014

Organisation Name: Multidisciplinary Association for Psychedelic Studies

Overal Status: Completed

Start Date: December 24, 2018

Last Update: June 29, 2022

Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Brief Summary: This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with at least severe PTSD. The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of MDMA or placebo, followed by a supplemental half-dose, unless contraindicated, during the Treatment Period with manualized therapy 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.

  • Posttraumatic Stress Disorder

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