Adapted Massed Exposure Therapy Enhanced with MDMA for PTSD (aMETEMP): A randomized, double-masked protocol adapted for Veterans Affairs healthcare system
Leslie A. Morland, Bettye E Chargin, Barbara Olasov Rothbaum, Jessica L Maples-Keller, Tamara R Wachsman, S.B. Norman, S.N. Adams, Dimitri Perivoliotis, A. Alam, Christopher S. Stauffer, Abigail C. Angkaw, V. Marquez, J B Woolley, Jared M. Kopelman, Paula P. Schnurr
Contemporary Clinical Trials Communications October 27, 2026 DOI: 10.1016/j.conctc.2026.101705 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized, double-masked, pilot trial (clinical protocol) Pilot study Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | U.S. veterans with PTSD receiving care in a Veterans Affairs outpatient setting |
| Interventions | MDMA Massed prolonged exposure (PE) therapy |
| Dose | 35mg - 125mg |
| Duration | 3-week massed exposure protocol; 28-30hrs total over 11 visits |
| Measures | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) |
| Topics | MDMA PTSD |
| Registration | NCT06117306 |
| Key findings | Describes the methodology of an ongoing pilot trial testing MDMA-enhanced massed prolonged exposure (aMETEMP) for veterans with PTSD, using an 'incomplete disclosure' masking strategy after the first four participants. The trial is designed to assess feasibility, safety/tolerability, masking integrity, and preliminary symptom-change signals rather than to establish efficacy. |
Abstract
Posttraumatic stress disorder (PTSD) remains prevalent and disabling, especially among veterans, with a substantial proportion failing to achieve remission following first-line evidence-based trauma-focused psychotherapies. 3,4-Methylenedioxymethamphetamine (MDMA) is hypothesized to enhance psychotherapy outcomes through effects on fear extinction, cognitive flexibility, and emotional engagement, and is being studied as a promising augmentation strategy for PTSD psychotherapy. There is limited research combining MDMA with evidence-based PTSD treatment. MDMA-assisted psychotherapy trials to date have also been limited by lack of an active comparator and functional unmasking. We describe the methodology of an ongoing randomized, double-masked, pilot trial evaluating massed prolonged exposure (PE) therapy enhanced with MDMA for PTSD (aMETEMP), adapted for a U.S. Veterans Affairs outpatient setting. Up to 20 veterans with PTSD in the VA will receive a 6-8hr in-person MDMA dosing session (randomized dose 35mg - 125mg) integrated with a 3-week massed exposure protocol. The remaining visits are virtual and include PE sessions and sessions to prepare for and process the MDMA session (28-30hrs total over 11 visits), with the use of telehealth intended to improve access and ease patient burden. After treating the first 4 participants, who were fully informed of the trial design, we switched to using an incomplete disclosure strategy (not disclosing the number of treatment arms or specific possible doses) to further improve masking. Primary outcomes include PTSD severity using the Clinician-Administered PTSD Scale for DSM-5, safety, feasibility, and masking success. Findings are intended to provide preliminary descriptive information regarding feasibility, safety/tolerability, masking integrity, and symptom-change signals for aMETEMP with incomplete disclosure in a large outpatient healthcare system.ClinicalTrials.gov Identifier: NCT06117306
Comparable studies
Other randomized controlled trials on MDMA for PTSD, most cited first.
Citations in the library
Cites 19
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- 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers: a randomised, double-blind, dose-response, phase 2 clinical trial. The Lancet Psychiatry May 1, 2018
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- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- Psychedelics reopen the social reward learning critical period Nature June 14, 2023
and 14 more in the library