MDMA for PTSD

155 papers and 53 clinical trials exploring mdma as a treatment for ptsd.

Blossom tracks 155 papers and 53 clinical trials examining mdma as a treatment for ptsd. MDMA acts primarily as a monoamine releaser (sert/net/dat). The papers and trials below are sorted by recency, and reported adverse events and dosing protocols are summarised in the linked overviews.

MDMA PTSD Adverse events Dose summary Clinical guidelines

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

IndicationAround 3.9% of people develop PTSD in their lifetime

PTSD

Post-traumatic stress disorder (PTSD) is where psychedelic medicine has its most famous result and its hardest reality check. MDMA-assisted therapy ran the only completed Phase 3 programme for any psychedelic in PTSD, with striking numbers, yet in August 2024 the US regulator declined to approve it and asked for another trial. This page sets the strongest evidence in the field beside the unresolved doubts about blinding, durability and trial conduct that the regulator flagged.

Full PTSD profile

Safety summary

MDMA for PTSD: adverse events

MDMA safety reports for PTSD most often include headache, insomnia, anxiety, fatigue among the source-backed named adverse events currently normalized in Blossom.

11 source papers|176 named AE rows|Top events: headache, insomnia, anxiety

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Dose summary

MDMA for PTSD: dose summaries

MDMA clinical studies for PTSD include 26 structured dose rows across 18 linked trials. Common source-reported dose patterns include 125 mg, 25 mg, 80-180 mg. Interpret these as descriptive trial protocols, not treatment recommendations.

32 source papers|26 dose rows|Patterns: 125 mg, 25 mg, 80-180 mg

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Clinical guidelines

MDMA clinical practice guidance

Blossom tracks 16 trial-anchored clinical guidelines for mdma, covering screening, dosing-session facilitation, safety, and integration competencies relevant to ptsd research.

16 guidelines|MDMA protocol family

View MDMA guidelines

Academic Research

155 papers

Open Accessindividual

Psychedelic-assisted therapy: a survey on the clinical methods of Swiss physicians

This survey study (n=41) examined how Swiss physicians provide psychedelic-assisted therapy under legal exemptions, mainly for depression, anxiety, PTSD and chronic pain. It found wide variation in practice, with psilocybin, MDMA and LSD commonly used, music often played during sessions, and adverse effects usually including disorientation, feeling cold, anxiety and nausea.

Published: May 20, 2026
Journal: Therapeutic Advances in Psychopharmacology
Authors: Beichmann, K., Catzeflis, P., Aicher, H. D., Seragnoli, F., Calder, A., Amrani, A., Hasler, G.

Paywallindividual

From trials to clinics: investigators' perspectives on translating psychedelic research into clinical care

This qualitative study (n=21) interviewed US psychedelic clinical investigators about how treatments such as MDMA and psilocybin might move from trials into routine care. They saw major challenges in the role of psychotherapy, treatment cost and scalability, and the effects of hype and stigma on uptake.

Published: May 19, 2026
Authors: Mitchell, J., Neitzke-Spruill, L., Mathai, D. S., Robinson, J. O., Kavan, Z., Averil, L. A., McGuire, A. L.

Open Accessmeta

A living systematic review, meta-analysis, and open data resource of trials of MDMA-assisted therapy for PTSD

This living systematic review and meta-analysis (s=6) of randomised controlled trials (n=286) found that MDMA-assisted therapy was linked to greater short-term reductions in PTSD symptoms than control treatment, with higher response and remission rates. The overall certainty of the evidence was low, and the authors noted that the online resource will be updated as new trial data emerge.

Published: March 30, 2026
Journal: MedRvix
Authors: Sevchik, B. L., Singleton, S. P., Lahey, A., Cuijpers, P., Harrer, M., Jones, M. T., Nayak, S. M., Strain, E. C., Vandekar, S. N., Yaden, D. B., Dworkin, R. H., Scott, J. C., Satterthwaite, T. D.

Open Accessmeta

Psychedelic medicine: mechanisms, evidence, and translation to practice

This review (2026) summarises the rapidly growing evidence for psychedelic-assisted therapies, finding the strongest support for psilocybin in treatment-resistant depression (TRD) and MDMA in post-traumatic stress disorder (PTSD). It also highlights that while these treatments are generally well tolerated in controlled settings, major challenges remain around unclear mechanisms, trial limitations, scalability, and translation into routine practice.

Published: February 23, 2026
Journal: BMJ
Authors: Jacobs, E., Zahid, Z., Hinkle, J., Nayak, S., Yaden, D. B.

Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published: February 18, 2026
Journal: JAMA Psychiatry
Authors: Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.

Paywallindividual

MDMA-Assisted Therapy for Major Depressive Disorder: A Seven-Month Follow-Up Proof of Principle Trial

This long-term follow-up (n=12) of participants with moderate-to-severe major depressive disorder who received MDMA-assisted therapy (two dosing sessions integrated with nine psychotherapy sessions) found significant reductions in depression severity and functional impairment at seven months compared to baseline, with improvements maintained from the post-treatment assessment and no increases in suicidal ideation.

Published: February 1, 2026
Journal: Journal of Psychiatric Research
Authors: Kvam, T. M., Goksøyr, I. W., Rog, J., van de Vooren, I. T. J., Stewart, L. H., Autran, I., Berthold-Losleben, M., Mørch-Johnsen, L., Holst, R., Røssberg, J. I., Clausen, I., Andreassen, O. A.

Clinical Trials

53 trials

CompletedPhase II

A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)

This Phase II, two-part, multicentre trial (n=64) will assess methylone as a treatment for adults with post-traumatic stress disorder (PTSD). It is designed to evaluate the drug’s safety, tolerability, and efficacy in participants aged 18–65 years in the UK, including people who have previously tried at least one PTSD treatment without sufficient benefit.

Type: interventional
Blinding: double
Randomized: Yes

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 II

MDMA-Assisted Massed Exposure Therapy for PTSD

This Phase II, randomised, triple‑blind, parallel trial (n=200) will evaluate whether a single 100 mg oral dose of MDMA given adjunctively with massed Prolonged Exposure (PE) therapy improves PTSD symptom severity and related neural measures in adults with post‑traumatic stress disorder (age 21–70 years), with the primary outcome being change in Clinician‑Administered PTSD Scale for DSM‑5‑Revised (CAPS‑5‑R) score from baseline to one month post‑treatment. Participants will be randomised to MDMA + massed PE or placebo + massed PE; MDMA is administered as a 100 mg capsule under supervision at Visit 2 of a course of 10 daily PE sessions delivered over two weeks (11 therapy sessions total, including an additional session during Visit 2), and the placebo visually matches the three MDMA capsules (40mg, 40mg, and 20mg). The study will also assess response efficiency and durability of symptom improvement and explore extinction retention and amygdala threat reactivity (neuroimaging), with safety and blinded independent evaluator CAPS‑5‑R assessments at the one‑month post‑treatment follow‑up; the trial is sponsored by Emory University with an anticipated start in January 2026 and completion in January 2030.

Started: January 1, 2026
Type: interventional
Blinding: triple
Randomized: Yes
Registry ID: NCT07288151

RecruitingPhase II

Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events

This Phase II, randomised, open-label, non-inferiority trial (n=168) will evaluate the safety, tolerability and effectiveness of group-based MDMA-assisted therapy compared with individual MDMA-assisted therapy in adults (18–75 years) with PTSD diagnosed following the events of 7 October 2023. The primary outcomes are change in PTSD symptoms measured by CAPS-5 and PCL-5 from baseline to end-of-treatment (Week 17 in the group-based arm; Week 13 in the individual arm). Eligible participants will be randomised to either group-based MDMA-assisted therapy (groups of up to 7 participants with the same trauma type) or individual MDMA-assisted therapy; both arms include preparatory sessions, three MDMA dosing sessions and integration sessions. MDMA HCl is administered orally in a divided dose with a supplemental dose 1.5 to 2 hours after the initial dose: first dosing session 80 mg with 40 mg supplemental, second and third dosing sessions 120 mg with 60 mg supplemental. Dosing sessions include on-site monitoring of vital signs, overnight stay after sessions and safety assessments (physical exam, urine drug screen, ECG, laboratory tests), with adverse events and suicidality monitored (C-SSRS) and oversight by an external DSMB; estimated enrolment is 168, with study start 24 December 2025 and completion anticipated 31 March 2029.

Started: December 24, 2025
Type: interventional
Blinding: none
Randomized: Yes
Registry ID: NCT07469098

WithdrawnPhase II

MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents

This open-label fixed-dose trial (n=10) aims to determine the safety and feasibility of MDMA-assisted psychotherapy (80-120mg) for adolescents with treatment-resistant post-traumatic stress disorder (PTSD).

Started: July 1, 2025
Type: interventional
Blinding: none
Randomized: No
Registry ID: NCT06353282

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

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Search all MDMA papers Search all PTSD trials Full MDMA profile Full PTSD profile