CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Midomafetamine +1 moredrug
Likely dose
Midomafetamine 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03282123
NCT03282123Phase 2Completed
CompareCT.gov

An Open-Label, Multi-Site Phase 2 Study of the Safety and Effect of Manualized MDMA-Assisted Therapy for the Treatment of Severe Posttraumatic Stress Disorder

Resilient Pharmaceuticals·interventional·Posted Sep 13, 2017·Updated Jun 5, 2025

In Brief

A Phase 2 clinical trial evaluating Midomafetamine and Manualized therapy for PTSD. Completed, enrolled 38 participants across 12 sites.

Detailed Summary

The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people diagnosed 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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 13, 2017
Enrollment StartNov 16, 2017
Primary CompletionAug 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 8.8 years ago

Interventions

Midomafetaminedrug

80 to 120 mg MDMA

Manualized therapybehavioral

Non-directive therapy conducted during MDMA-assisted therapy session