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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
|
RCT (pilot) |
|
↑Supports
|
MDMA-assisted psychotherapy reduced PTSD symptoms more than placebo therapy. |
|
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
|
RCT (phase 2, dose-response) |
|
↑Supports
|
The active MDMA dose produced significant and lasting PTSD symptom reductions compared with 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 (pilot) |
12 |
↕Mixed
|
Full-dose MDMA-assisted psychotherapy produced significant self-reported PTSD improvement but clinician-rated CAPS reductions were not statistically significant; no drug-related serious 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 |
19 |
↑Supports
|
Symptom gains were maintained over a mean of 45.4 months with no reported harm or drug dependency, though two participants relapsed. |
|
Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study.
2018
|
RCT (pilot) |
12 |
↑Supports
|
MDMA-assisted psychotherapy produced significantly greater and durable reductions in social anxiety than placebo, with very large effect sizes. |
|
Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA.
2016
|
review |
|
↑Supports
|
Psilocybin and MDMA show promise as adjuncts to psychotherapy for several difficult-to-treat conditions, including refractory PTSD and social anxiety in autistic adults. |
|
3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.
2018
|
RCT (phase 2, dose-response) |
28 |
↑Supports
|
Active MDMA doses (100 and 125 mg) produced larger PTSD symptom reductions than a 40 mg dose, 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
|
Proposes that MDMA-assisted psychotherapy for PTSD may work by enhancing memory reconsolidation and fear extinction via modulation of emotional memory circuits. |
|
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 studies with higher doses are needed. |
|
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline
2019
|
review |
|
↑Supports
|
Pooled Phase 2 data indicate a large effect size for MDMA-assisted psychotherapy for PTSD, with lower dropout than sertraline or paroxetine trials. |
|
MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study
2020
|
RCT (pilot) |
18 |
→No effect
|
MDMA-assisted psychotherapy produced a greater reduction in anxiety scores than placebo, but the group difference did not reach statistical significance. |
|
Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy.
2017
|
RCT (secondary analysis) |
|
↑Supports
|
Changes in openness, but not neuroticism, moderated the relationship between reduced PTSD symptoms and MDMA treatment, with increased openness and decreased neuroticism at long-term follow-up. |
|
A Review of 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy
2019
|
review |
|
↑Supports
|
Reviews MDMA-assisted psychotherapy for PTSD as entering Phase 3 trials, with additional potential applications in autism-related anxiety and alcohol use disorder. |
|
Oncology Providers' Perspectives on Psychedelic-Assisted Therapy.
2026
|
cross-sectional survey |
385 |
↓Opposes
|
Most oncology providers (80%) were uncomfortable counseling patients on psychedelic-assisted therapy and only 44% were familiar with its legal status; willingness to recommend it was linked to familiarity with emerging data and legal knowledge. |
|
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. |
|
Making a case for using MDMA-assisted psychotherapy for borderline personality disorder and complex PTSD: a descriptive systematic review of the literature
2026
|
systematic review |
335 |
↕Mixed
|
Most studies reported reduced PTSD symptoms after MDMA-assisted psychotherapy, but no studies directly assessed complex PTSD or borderline personality disorder, so applicability to those conditions remains hypothetical. |
|
Psychedelic-Assisted Psychotherapy for the Treatment of PTSD: A Systematic Review and Meta-Analysis
2026
|
systematic review and meta-analysis |
358 |
↑Supports
|
MDMA-assisted psychotherapy showed a significant moderate-to-large reduction in PTSD symptom severity with negligible heterogeneity, while ketamine and cannabidiol did not show clear benefit. |
|
From therapeutic promise to evidentiary discipline: Reassessing MDMA-assisted psychotherapy for posttraumatic stress disorder.
2026
|
commentary |
|
?Unclear
|
Argues that blinding difficulties, expectancy effects, absence of robust active comparators, limited mechanistic clarity, and safety-monitoring and generalizability concerns are central to interpreting MDMA-assisted psychotherapy, and that recovery indicators beyond symptom reduction are needed. |
|
MDMA-Assisted Psychotherapy for Cluster B Personality Disorders: A Narrative Review of This Translational Framework for Relational Healing
2026
|
narrative review |
|
?Unclear
|
Proposes that MDMA-assisted psychotherapy may be a promising adjunct for Cluster B personality disorders by targeting attachment, trust, and emotion-regulation deficits, while noting empirical evidence remains limited. |
|
Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study.
2026
|
Delphi tool development |
12 |
↑Supports
|
Expert consensus produced a 165-item tool (M-SET) to systematically assess side effects of MDMA-assisted psychotherapy across screening, baseline, dosing, and follow-up. |
|
State of the Science: MDMA‐assisted psychotherapy for the treatment of posttraumatic stress disorder
2026
|
review |
|
↕Mixed
|
MDMA-assisted psychotherapy has shown promising response and remission rates in randomized trials, but the FDA declined approval in August 2024 citing insufficient evidence, and blinding, active comparators, safety monitoring, and generalizability remain limitations. |
|
MDMA-assisted psychotherapy in major depression: critical considerations for clinical translation: commentary, Kvam et al.
2026
|
commentary |
|
?Unclear
|
Argues that MDMA-assisted psychotherapy for major depression requires further rigorous study to address methodological and ethical concerns before clinical translation. |
|
Experiences of Australian clinicians, researchers, and patients with MDMA-assisted psychotherapy for post-traumatic stress disorder: A framework-guided qualitative analysis.
2026
|
qualitative study |
21 |
↑Supports
|
Participants described perceived therapeutic benefits and emphasized expectation management, comprehensive screening, consent, therapeutic alliance, integration of care, and provider training. |