At a glance
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An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Therapy Session in People Who Relapsed After Participating in a Phase 2 Clinical Trial of MDMA-Assisted Therapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder
In Brief
A Phase 2 clinical trial evaluating Midomafetamine and Therapy for Posttraumatic Stress Disorder. Completed, enrolled 3 participants across 1 site.
Detailed Summary
This study will consist of a single session of MDMA-assisted therapy with a full dose of MDMA for people who took part in a study of MDMA-assisted therapy in people with posttraumatic stress disorder (PTSD) whose PTSD symptoms returned to higher levels at least a year after the first MDMA sessions. The single session will be performed by the same pair of therapists who performed the sessions in the first study. People will have a preparatory session, the MDMA-assisted session and three non-drug sessions afterward. Their PTSD symptoms and symptoms of depression will be measured at the start of this study and two and 12 months after the session.
Study Details
Timeline
Interventions
125 mg MDMA followed by 62.5 mg MDMA 1.5 to 2.5 hours later
Non-directive therapy