MDMA-assisted psychotherapy for the treatment of PTSD: A systematic review and meta-analysis of randomized controlled trials (RCTs).
Ghada Shahrour, Kainat Sohail, Safa Elrais, Muhammad Hamza Khan, Javeria Javeid, Khubaib Samdani, Hajra Mansoor, Syed Izhar Hussain, Dhruvikumari Sharma, Muhammad Ehsan, Abdulqadir J Nashwan
Neuropsychopharmacology Reports December 1, 2024 DOI: 10.1002/npr2.12485 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review and meta-analysis Randomized Peer reviewed |
|---|---|
| Sample size | 297 |
| Population | Individuals with chronic, treatment-resistant PTSD |
| Intervention | MDMA-assisted psychotherapy |
| Dose | 25-40 mg |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | MDMA‐At Rcts Meta‐analysis Post‐traumatic stress disorder Trauma therapy Psychedelic Medicine MDMA MDMA-Assisted Therapy MDMA-At |
| Citations | 21 |
| Key findings | MDMA-assisted psychotherapy significantly reduces PTSD symptom severity and increases response and remission rates compared to control conditions, with a favorable safety profile. |
Abstract
Post-traumatic stress disorder (PTSD) is a mental health disorder resulting from exposure to traumatic events, manifesting in various debilitating symptoms. Despite available treatments, many individuals experience inadequate response or significant side effects. Previous reviews suggest promising outcomes with MDMA-assisted psychotherapy (MDMA-AT), but limitations prompt the need for a comprehensive evaluation. We searched various online databases and registries such as MEDLINE (via PubMed), Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov to retrieve RCTs that fit our inclusion criteria. We performed meta-analyses using Review Manager by applying a random-effects model. Dichotomous and continuous outcomes were pooled as risk ratios (RR) and standard mean difference (SMD), respectively. Nine studies with a total of 297 participants with PTSD were included in our meta-analysis. The control group consisted of inactive doses of MDMA (25-40 mg) or placebo. Our meta-analysis showed that MDMA-AT led to a significant reduction in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) severity scores as compared to the control group (SMD -1.10, 95% CI: -1.62 to -0.59). More patients in the MDMA-AT group exhibited significant response (RR 1.59, 95% CI: 1.22, 2.08) and remission (RR 2.32, 95% CI: 1.47 to 3.66) as compared to patients in the control group. There was no significant difference regarding the incidence of ≥1 treatment-emergent adverse events (TEAE), ≥1 severe TEAE, and suicidal ideation between the two groups. MDMA-AT demonstrates significant efficacy in improving PTSD symptoms, enhancing both response and remission rates in individuals with chronic, treatment-resistant PTSD, while maintaining a favorable safety profile.
Comparable studies
Other systematic reviews and meta-analyses on MDMA and psychedelic-assisted therapy, most cited first.
Citations in the library
Cited by 18
- Use of psychedelic treatments in psychiatric clinical practice: an EPA policy paper European Psychiatry 2025
- Blinding Integrity in Psychedelic Randomized Clinical Trials JAMA Psychiatry April 15, 2026
- Novel psychedelic interventions for post-traumatic stress disorder and their promise for precision medicine. Therapeutic Advances in Psychopharmacology December 4, 2025
- Efficacy and Safety of Psychedelics in Mental Disorder Cases: An Umbrella Review of Meta-Analyses of Randomized Controlled Trials Journal of Clinical Medicine December 29, 2025
- Can ketamine and other glutamate receptor modulators be considered entactogens? Psychiatry Research July 1, 2025
and 13 more in the library
Cites 21
- The safety and efficacy of {+/-}3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. Journal of Psychopharmacology July 19, 2010
- 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
- A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD) Journal of Psychopharmacology October 31, 2012
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Journal of Psychopharmacology 2013
and 16 more in the library