|
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
2021
|
RCT |
90 |
↑Supports
|
MDMA-assisted therapy produced significantly greater reductions in PTSD symptoms (d = 0.91) and functional impairment (d = 0.43) than placebo with therapy, with no serious adverse events. |
|
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.
2010
|
randomized controlled pilot study |
|
↑Supports
|
MDMA-assisted psychotherapy reduced PTSD symptoms more than placebo therapy in people with chronic, treatment-resistant PTSD. |
|
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.
2018
|
randomized, double-blind, dose-response phase 2 trial |
|
↑Supports
|
The active dose of MDMA-assisted psychotherapy led to significant and lasting reductions in PTSD symptoms compared to a lower dose. |
|
A randomized, controlled pilot study of MDMA (±3,4-Methylenedioxymethamphetamine)-assisted psychotherapy for treatment of resistant, chronic Post-Traumatic Stress Disorder (PTSD)
2012
|
RCT |
12 |
↕Mixed
|
MDMA-assisted psychotherapy was safely administered and produced statistically significant self-reported improvement (PDS, p = 0.014), but clinician-rated CAPS reductions were not statistically significant (p = 0.066); CAPS scores improved further at 1-year follow-up. |
|
MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial.
2023
|
RCT |
104 |
↑Supports
|
MDMA-assisted therapy reduced PTSD symptoms (d = 0.7) and functional impairment (d = 0.4) more than placebo with therapy; no deaths or serious treatment-emergent adverse events occurred. |
|
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.
2013
|
long-term follow-up of a completed trial |
19 |
↑Supports
|
Gains in symptom relief were maintained over an average of 45.4 months with no statistical difference between end-of-study and follow-up CAPS scores, though two of 16 completers relapsed. |
|
Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA.
2016
|
review |
|
↑Supports
|
MDMA is showing encouraging results as a treatment for refractory PTSD when used as an adjunct to psychotherapy, though further research is needed. |
|
3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.
2018
|
RCT |
28 |
↑Supports
|
Active MDMA doses (100 and 125 mg) produced larger CAPS reductions than a 40 mg low dose, reaching significance only in the per-protocol set (p = 0.03), with 76% no longer meeting PTSD criteria at 12-month follow-up. |
|
MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?
2018
|
review |
|
↑Supports
|
Argues that MDMA-assisted psychotherapy may work by enhancing memory reconsolidation and fear extinction via modulation of emotional memory circuits, and cites durable remission in 68% of Phase 2 participants. |
|
MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder
2008
|
observational cohort |
6 |
↑Supports
|
Low doses of MDMA (50-75 mg) were psychologically and physiologically safe in all six women, with preliminary efficacy data; larger samples and doses are needed. |
|
Clinical applications of hallucinogens: A review.
2016
|
review |
|
↑Supports
|
A growing body of evidence indicates hallucinogens including MDMA may have therapeutic applications beyond their potential for abuse. |
|
MDMA‐Assisted Psychotherapy for Treatment of Posttraumatic Stress Disorder: A Systematic Review With Meta‐Analysis
2021
|
systematic review with meta-analysis |
|
↑Supports
|
MDMA-assisted psychotherapy reduced CAPS scores more than control psychotherapy (mean difference -22.03) with high heterogeneity, and increased rates of clinically significant improvement (RR 3.65) and loss of PTSD diagnosis (RR 2.10). |
|
Registered clinical studies investigating psychedelic drugs for psychiatric disorders.
2021
|
review |
70 |
?Unclear
|
As of December 2020, 70 registered trials were investigating psychedelics for psychiatric disorders, mostly MDMA and psilocybin for PTSD and major depressive disorder, but only 21 had published results. |
|
[The use of psychedelics in psychiatry].
2026
|
review |
|
↕Mixed
|
Argues that MDMA-assisted psychotherapy has the largest phase 3 dataset in PTSD but was declined FDA approval in 2024 on ethical grounds, and that certainty of evidence remains low or very low for several indications. |
|
A Systematic Review of MDMA’s Effects on Social Cognition in Placebo-Controlled Trials
2026
|
systematic review |
75 |
↕Mixed
|
MDMA consistently enhanced subjective social experience but behavioural prosociality was inconsistent and context dependent, and MDMA reduced accuracy in identifying negative social cues. |
|
MDMA-Assisted Therapy May Decrease PTSD Symptoms, Dissociation, Depression, and Functional Disability: A Systematic Review and Meta-Analysis
2026
|
systematic review and meta-analysis |
|
↑Supports
|
Across seven RCTs, MDMA-assisted psychotherapy may significantly improve PTSD symptoms, dissociation, depression, and functional impairment but not sleep quality, with limitations including small samples, blinding challenges, non-standardized therapies, and a common sponsor. |
|
Healing together: Results from a pilot trial of 3,4-Methylenedioxymethamphetamine-enhanced cognitive-behavioral conjoint therapy for posttraumatic stress disorder.
2026
|
pilot trial |
|
↑Supports
|
MDMA-enhanced cognitive-behavioral conjoint therapy was feasible and acceptable and was associated with clinically meaningful reductions in PTSD symptoms and improved relationship satisfaction. |
|
717. Clinical trials, ethical dimensions, and the pathway of MDMA-assisted therapy in PTSD
2026
|
literature review |
|
?Unclear
|
Argues that MDMA-assisted therapy trials raise distinctive ethical issues due to MDMA's affective and cognitive effects, which may heighten patient vulnerability, alter memory and beliefs, and complicate informed consent. |
|
MDMA-Enhanced Exposure Therapy Reverses PTSD-Like Features In a Learned Helplessness Mouse Model
2026
|
preclinical study |
|
↑Supports
|
MDMA combined with exposure to a traumatic cue produced rapid and sustained recovery in trauma-susceptible mice, with dose-dependent effects on anxiety- and depression-related measures. |
|
The occurrence and potential role of mystical experiences in MDMA-assisted therapy for PTSD: A secondary analysis
2026
|
secondary analysis of two phase 2 RCTs |
53 |
↕Mixed
|
MDMA sessions produced significantly higher MEQ30 mystical experience scores than placebo, and the Positive Mood subscale significantly mediated PTSD symptom reduction, while total and other subscale effects were non-significant. |
|
Prevalence of Potential Contraindications and Risk Factors Relevant to MDMA-Assisted Therapy Among U.S. Veterans with Posttraumatic Stress Disorder
2026
|
serial cross-sectional study |
326315 |
?Unclear
|
Each year 15.3-17.3% of veterans with PTSD had at least one contraindication for MDMA-assisted therapy, 55.2-58.2% had a conditional or modifiable risk factor, and 85.7-87.5% filled a prescription for a potentially interacting medication. |
|
MDMA as an early post-trauma intervention in a translational animal model of PTSD.
2026
|
controlled animal study |
175 |
↑Supports
|
MDMA at 10 mg/kg given 30 minutes after stress or 24 hours later with trauma-cue pairing reduced anxiety-like behavior, startle, and freezing, whereas lower doses and unpaired delayed administration were ineffective. |
|
Changes in trauma symptoms of discrimination after MDMA-assisted psychotherapy for posttraumatic stress disorder.
2026
|
preliminary study |
5 |
↑Supports
|
MDMA-assisted therapy significantly reduced discrimination-related trauma symptoms, with a 38% decrease in TSDS scores and a large effect size (d = 1.28), though the sample was very small. |