At a glance
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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 Posttraumatic Stress Disorder of Moderate or Greater Severity
In Brief
A Phase 3 clinical trial evaluating Therapy, Midomafetamine, and 1 other intervention for Posttraumatic Stress Disorder. Completed, enrolled 121 participants across 14 sites in 2 countries.
Detailed Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.
Study Details
Timeline
Interventions
Standardized non-directive therapy performed by therapist team.
Administration of 80 to 120 mg midomafetamine HCl, followed by a supplemental half-dose 1.5 to 2 hrs after the initial dose of 40 or 60 mg, respectively, during three sessions of MDMA-assisted psychotherapy.
Administration of placebo with therapy during three experimental sessions