CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
MDMA +1 moredrug
Likely dose
MDMA 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/NCT05961527
NCT05961527Phase 2Completed
CompareCT.gov

An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans

Portland VA Research Foundation, Inc·interventional·Posted Jul 27, 2023·Updated Jun 12, 2025

In Brief

A Phase 2 clinical trial evaluating MDMA and Group Therapy for PTSD. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPTSD
CountriesUnited States
CollaboratorsSteven & Alexandra Cohen Foundation

Timeline

Phase 2CompletedFinished
202420252026
First PostedJul 27, 2023
Enrollment StartOct 1, 2023
Primary CompletionMar 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.9 years ago

Interventions

MDMAdrug

Initial dose of 120 mg MDMA HCL and optional supplemental dose of 60 mg MDMA HCL at 1.5 to 2 hours after first dose

Group Therapybehavioral

Standardized group psychotherapy performed by therapist team in combination with non-directive MDMA therapy