Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (MPG1)

This Phase 2, 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 and receive therapy sessions throughout their participation in these groups.

Topic PTSD
Compound MDMA
Country United States of America
Visit trial
Status Not yet recruiting
Results Published
Start date 01 June 2022
End date 07 June 2023
Chance of happening 89%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 18
Sex All
Age 18- 99
Therapy Yes

Trial Details

To further assess the feasibility, efficacy, and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided dose of MDMA, along with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary 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 NCT05173831

Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Measures Used

Clinician-Administered PTSD Scale for DSM-5
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is often considered the gold standard in PTSD assessment. The 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Centre for PTSD. CAPS can be used to make a current diagnosis, lifetime diagnosis or assess PTSD symptoms over the past week in accordance with DSM-5 criteria.

Data attribution

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