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Home/Research/MDMA/Veterans

MDMA for Veterans

15 papers and 14 clinical trials exploring mdma as a treatment for veterans.

Compoundempathogen

MDMA

MDMA is a synthetic empathogen that enhances monoamine release, producing prosocial and anxiolytic effects without frank hallucinosis. Two Phase III trials demonstrated significant PTSD symptom reductions, though FDA review raised concerns about blinding, durability, and safety characterisation.

Full MDMA profile
Indication~7% of veterans develop PTSD in their lifetime

Veterans

Veterans carry an unusually heavy burden of PTSD, depression, traumatic brain injury, moral injury and suicidality, and many do not respond to standard treatment. That unmet need has put them at the centre of psychedelic research, and of an intense real-world demand. The evidence is genuinely promising but still early and mostly uncontrolled, and in 2024 the US FDA declined to approve MDMA-assisted therapy for PTSD.

Full Veterans profile

Academic Research

15 papers
Open Accessindividual

Inflammatory biomarker outcomes associated with MDMA-assisted therapy: an open-label exploratory study

This open-label exploratory study (n=23) examined inflammatory biomarkers in Veterans with PTSD during MDMA-assisted group therapy and found small changes in interleukin-6, tumour necrosis factor alpha and C-reactive protein. Higher baseline inflammation was linked with worse PTSD symptoms, and changes in interleukin-6 were related to symptom improvement.

Published
March 23, 2026
Journal
Frontiers in Neuroscience
Authors
Kachmarik, J. E., Loftis, J. M., Stauffer, C. S.
Open Accessindividual

The Potential Economic and Public Health Impact of MDMA-Assisted Group Therapy for PTSD in Ukraine

Using a decision-analysis model for 1,000 Ukrainian PTSD patients, the study estimates MDMA-assisted group therapy with supplemental individual sessions would cost US$1.1m, avert 19.2 deaths, gain 717 QALYs, have an ICER of US$1,537/QALY and produce net societal savings of US$2.6m, with scaled 50% coverage over 10 years potentially saving ~48,000 lives, 1.5 million QALYs and US$5.6bn. These results indicate MAT is likely to be cost‑effective or cost‑saving and could substantially improve population health, supporting its inclusion in Ukraine’s PTSD treatment strategy.

Published
August 21, 2025
Journal
World Medical & Health Policy
Authors
Marseille, E., Chernoloz, O., Orlov, |. O.
Open Accessindividual

Cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) in chronic and treatment-resistant post-traumatic stress disorder of moderate or higher severity: A health-economic model

Using a health state-transition model, midomafetamine-assisted therapy for chronic, moderate-or-higher PTSD produced a 0.377 QALY gain over five years at an incremental cost of $31,613, yielding an ICER of $83,845 per QALY. These results indicate MDMA-AT is likely cost-effective versus placebo with therapy at a $150,000 willingness-to-pay threshold (assuming a $12,000 per-session drug price).

Published
November 12, 2024
Journal
PLOS ONE
Authors
Stanghellini, G.
Open Accessmeta

Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement

A multidisciplinary group produced a consensus ethics and policy framework for integrating government‑approved psychedelic medicines into clinical care, articulating 20 consensus points across five core ethical domains. The statement assigns responsible actors for implementation and identifies areas for further research and policy deliberation to promote equitable, safe adoption in mainstream medicine.

Published
June 4, 2024
Journal
JAMA Network Open
Authors
McGuire, A. L., Cohen, I. G., Sisti, D., Baggott, M., Celidwen, Y., Devenot, N., Gracias, S., Grob, C. S., Harvey, I., Kious, B., Marks, M., Mithoefer, M. C., Nielson, E. M., Öngür, D., Pallas, A., Peterson, A., Schenberg, E. E., Summergrad, P., Waters, B., Williams, M. T., Yaden, D. B.
Open Accessmeta

MDMA Assisted Psychotherapy Decreases PTSD Symptoms, Dissociation, Functional Disability, and Depression: A Systematic Review and Meta-Analysis

This pre-print review and meta-analysis (2023) of randomised controlled trials (RCTs) assessed the effectiveness of MDMA-assisted psychotherapy (MDMA-AP/AT) for treating Post-Traumatic Stress Disorder (PTSD) and its impact on quality of life and physiological effects. The analysis found that MDMA-AP significantly improved dissociation, depression, and functional impairment in PTSD patients compared to controls, but not sleep quality.

Published
August 20, 2023
Journal
MedRvix
Authors
Green, W. M., Raut, S. B., James, F. L. J., Benedek, D. M., Ursano, R. J., Johnson, L. R.
Open Accessindividual

Altered brain activity and functional connectivity after MDMA-assisted therapy for post-traumatic stress disorder

In nine veterans and first‑responders with chronic PTSD, fMRI before and two months after MDMA‑assisted therapy showed reduced trauma‑related cuneus activation and clinical improvement that correlated with changes in connectivity involving the left amygdala (bilateral PCC and left insula) and left isthmus cingulate–left posterior hippocampus, with a trend toward increased left amygdala–left hippocampus resting connectivity. These preliminary findings indicate MDMA‑AT modulates amygdala–hippocampus–insula networks implicated in PTSD recovery but require replication and comparison with other treatments.

Published
January 12, 2023
Journal
Frontiers in Psychiatry
Authors
Singleton, S. P., Wang, J. B., Mithoefer, A. T., Mithoefer, M. C., Hanlon, C., George, M. S., Coker, A., Yazar-Klosinski, B., Emerson, A., Doblin, R., Kuceyeski, A., Mithoever, O.

Clinical Trials

14 trials
Not yet recruitingPhase II

MDMA Therapy in Veterans With PTSD

This Phase II, randomised, open-label trial (n=52) will study the safety, tolerability and efficacy of MDMA-assisted therapy in adult veterans with post-traumatic stress disorder (PTSD). Participants will receive oral MDMA as part of therapy in either individual or group settings. The study is a single-centre, fixed-dose, parallel-group design with two experimental arms: individual therapy and group therapy. The MDMA regimen is 120 mg orally followed by a supplemental 60 mg dose, and the main outcomes are safety, tolerability and the Columbia Suicide Severity Rating Scale (C-SSRS) assessed over 15 months.

Started
May 1, 2026
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT07569159
RecruitingPhase I

Psilocybin and Methylenedioxymethamphetamine (MDMA) for Post-traumatic Stress Disorder (PTSD) (PAM-VET)

This Phase I, double-blind, active-controlled trial (n=40) will investigate the safety and potential therapeutic effects of co-administered MDMA and psilocybin in military Veterans diagnosed with post-traumatic stress disorder (PTSD).

Started
June 1, 2025
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06989957
RecruitingPhase II

Dose Optimization of MDMA-Assisted Therapy for PTSD (DosOp)

Open-label, within-subjects dose optimisation trial (n=60) in U.S. veterans with PTSD investigating the optimal number of MDMA-Assisted Therapy cycles (one MDMA session + three integration sessions).

Started
October 1, 2024
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT06418178
RecruitingPhase III

MDMA-assisted Massed Prolonged Exposure for PTSD

Randomized, quadruple-blind Phase III parallel pilot (n=20) evaluating MDMA-assisted Massed Prolonged Exposure (one MDMA medicine session plus 12 90-minute PE sessions) in US veterans with PTSD; doses randomized (exact doses not disclosed).

Started
January 2, 2024
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06117306
CompletedPhase III

MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD (MDMA-bCBCT)

Open-label single-group pilot (n=16 dyads, 8 PTSD+ veterans and their partners) testing MDMA-assisted bCBCT: 8-session therapy with two full-day MDMA sessions for PTSD+ veterans to evaluate preliminary effectiveness on PTSD and relationship functioning.

Started
October 6, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05979844
CompletedPhase I/II

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.

Started
October 1, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05961527

Explore further

Search all MDMA papers Search all Veterans trials Full MDMA profile Full Veterans profile