Group MDMA-therapy for Veterans With PTSD (Group-MVP)

This open-label, non-randomized Phase IIa trial (n=18) evaluates the feasibility and safety of MDMA-assisted group therapy for treating PTSD in veterans. Conducted by the Portland VA Research Foundation, the study employs a unique treatment package comprising two once-monthly open-label MDMA sessions combined with non-drug preparatory and integrative therapy, both individual and group-based.

The primary clinical outcome measure, the Clinician Administered PTSD Scale (CAPS-5), assesses changes in PTSD symptom severity. The therapy involves manualized MDMA-assisted therapy for PTSD, incorporating group therapy components. The study commenced on October 1, 2023, with an estimated primary completion date of July 31, 2025, and overall completion by September 30, 2025.

Participants, U.S. Military Veterans aged 18 to 64, fluent in the study site’s language, with a current PTSD diagnosis, are eligible. Exclusion criteria include uncontrolled hypertension, marked baseline QTcF interval >450 ms, and various medical conditions. The study design is interventional, combining MDMA and group therapy, with an estimated enrollment of 18 participants. The primary purpose is treatment, and it’s a Phase I/II study. The study arms include MDMA-assisted group therapy, and the intervention involves preparatory and integrative sessions, alongside the drug. The primary outcome measure is the change in CAPS-5 Total Severity Score over the baseline to 3 months from the first experimental session. Secondary outcomes include the Sheehan Disability Scale (SDS) total score.

The study is being conducted in Vancouver, Washington, United States, and is led by Kevin Rothstein-Kightly, MS, who can be contacted for study information. The Portland VA Research Foundation sponsors the trial, collaborating with the Steven & Alexandra Cohen Foundation. The study’s first submission to ClinicalTrials.gov was on July 17, 2023, and the first posted information appeared on July 27, 2023. The most recent update, meeting quality control criteria, was submitted on November 15, 2023, and posted on November 18, 2023.

Trial Details

To assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly open-label MDMA Sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Clinical Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components.

NCT Number NCT05961527

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.