Adapted Massed Exposure Therapy Enhanced with MDMA for PTSD (aMETEMP): A randomized, double-masked protocol adapted for Veterans Affairs healthcare system.
11 affiliations
- 1Department of Veterans Affairs National Center for PTSD Women's Health Sciences Division, 150 South Huntington Street, Boston, MA, 02130, USA.
- 2Veterans Affairs San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA, 92161, USA.
- 3Department of Psychiatry, University of California San Diego School of Medicine, 9500 Gilman Drive, La Jolla, CA, 92093, USA.
- 4Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 12 Executive Park Drive, Atlanta, GA, 30329, USA.
- 5San Diego State University/University of California San Diego Joint Doctoral Program in Clinical Psychology, 6363 Alvarado Court, San Diego, CA, 92120, USA.
- 6National Center for PTSD Executive Division, VA Medical Center, 215 N. Main Street, White River Junction, VT, 05009, USA.
- 7Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR, 97239, USA.
- 8Veterans Affairs Portland Health Care System, 3710 SW US Veterans Hospital Rd, Portland, OR, 97239, USA.
- 9Translational Psychedelic Research Program, Department of Psychiatry and Behavioral Sciences, Weil Center for Neuroscience, University of California, San Francisco, 2130 Fulton Street, San Francisco, CA, 94117, USA.
- 10Veterans Affairs San Francisco Healthcare System, 4150 Clement Street, San Francisco, CA, 94121, USA.
- 11Department of Psychiatry, Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road, Hanover, NH, 03755, USA.
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 35 mg - 125 mg) 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. NCT06117306.
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BibTeX
@article{morland2026adapted,
title = {{Adapted Massed Exposure Therapy Enhanced with MDMA for PTSD (aMETEMP): A randomized, double-masked protocol adapted for Veterans Affairs healthcare system.}},
author = {L A Morland and B Chargin and B Rothbaum and J L Maples-Keller and T Wachsman and S B Norman and S N Adams and D Perivoliotis and A Alam and C S Stauffer and A C Angkaw and V Marquez and J Woolley and J M Kopelman and P P Schnurr},
journal = {Contemporary clinical trials communications},
year = {2026},
month = oct,
doi = {10.1016/j.conctc.2026.101705},
url = {https://europepmc.org/article/MED/42999641},
note = {CC BY},
}
RIS
TY - JOUR
TI - Adapted Massed Exposure Therapy Enhanced with MDMA for PTSD (aMETEMP): A randomized, double-masked protocol adapted for Veterans Affairs healthcare system.
AU - L A Morland
AU - B Chargin
AU - B Rothbaum
AU - J L Maples-Keller
AU - T Wachsman
AU - S B Norman
AU - S N Adams
AU - D Perivoliotis
AU - A Alam
AU - C S Stauffer
AU - A C Angkaw
AU - V Marquez
AU - J Woolley
AU - J M Kopelman
AU - P P Schnurr
PY - 2026
DA - 2026/10/27
JO - Contemporary clinical trials communications
DO - 10.1016/j.conctc.2026.101705
UR - https://europepmc.org/article/MED/42999641
AB - 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 35 mg - 125 mg) 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. NCT06117306.
SN - 2451-8654
ER -