At a glance
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An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder (Canada)
In Brief
A Phase 2 clinical trial evaluating Midomafetamine HCl and Manualized therapy for Posttraumatic Stress Disorder. Completed, enrolled 4 participants across 2 sites.
Detailed Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with at least severe PTSD. The main question it aims to answer is: Do three open-label sessions of MDMA-assisted therapy reduce PTSD symptoms? Participants will receive three non-drug preparatory sessions followed by three sessions of MDMA-assisted therapy. Each MDMA-assisted therapy session is followed by three non-drug integrative therapy sessions.
Study Details
Timeline
Interventions
Three sessions of MDMA-assisted therapy with flexible dose of midomafetamine HCl from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
Non-directive therapy