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Clinical trial

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

Resilient PharmaceuticalsCompletedPhase 3Started Mar 8, 202187 enrolledUnited States, Canada, IsraelNCT04714359

Abstract

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.

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MDMAPTSD

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