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MDMA and psychedelic-assisted therapy

Studies whose primary subject is both MDMA and Psychedelic-assisted therapy, with an evidence synthesis read across the most-cited and most recent of them.

State of the evidence

Synthesized

Synthesized from 23 studies in the library · AI-generated, grounded in the abstracts below

Found by searching the library for MDMA, ecstasy, molly, methylenedioxymethamphetamine, Psychedelic-assisted therapy, psychedelic therapy, then ranked by relevance.

Across randomized trials, MDMA-assisted psychotherapy consistently produces larger reductions in PTSD symptoms than placebo or low-dose controls, with response rates around 76-83% in some trials and gains often maintained at 12-month follow-up; pooled meta-analysis supports a moderate-to-large effect. Evidence for other indications is thinner: social anxiety in autistic adults improved significantly in a small trial, while anxiety related to life-threatening illness showed a large but non-significant group difference. The main caveats are small samples, difficulty blinding, expectancy effects, few active comparators, and the fact that regulatory approval has not been granted.

Evidence by study

Direction is which way each study's own result points, not our rating of the study.

What the directions mean
Supports:
the study found the intervention worked, or its hypothesis held.
Opposes:
it found the opposite, no benefit or a harm.
No effect:
no significant difference either way.
Mixed:
effects in both directions within the same study.
Unclear:
the abstract does not report a direction.
Study Design Sample size Direction Finding
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 20 Supports MDMA-assisted psychotherapy produced significantly greater CAPS reductions than placebo at all post-baseline time points, with 83% versus 25% clinical response and no drug-related serious adverse events.
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 (double-blind, dose-response, phase 2) 26 Supports Active doses (75 and 125 mg) produced larger CAPS-IV reductions than a 30 mg control at one month, and symptoms remained reduced at 12 months after open-label full-dose MDMA.
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 Full-dose MDMA-assisted psychotherapy was safely administered and produced significant self-reported PTSD improvement, but clinician-rated CAPS reductions were not statistically significant (p = 0.066).
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 Mean CAPS scores at long-term follow-up (mean 45.4 months) did not differ from study exit, indicating maintained gains, 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 12 Supports MDMA-assisted psychotherapy produced significantly greater improvement in social anxiety scores than placebo at one month and at six-month follow-up, with large effect sizes.
Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA. 2016 review Supports Reports that psilocybin and MDMA show promise as adjuncts to psychotherapy for 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 doses (100 and 125 mg) produced larger CAPS reductions than a 40 mg dose, reaching significance only in the per-protocol set, and 76% no longer met PTSD criteria at 12 months.
MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms? 2018 review Supports Argues that MDMA-assisted psychotherapy may work through memory reconsolidation and fear extinction via monoamine, oxytocin, and cortisol effects on 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 reported.
Breakthrough for Trauma Treatment: Safety and Efficacy of MDMA-Assisted Psychotherapy Compared to Paroxetine and Sertraline 2019 review Supports Argues that pooled Phase 2 data show a large effect size for MDMA-assisted psychotherapy and lower dropout than paroxetine or sertraline trials.
MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study 2020 RCT 18 Mixed MDMA-assisted psychotherapy produced a larger reduction in anxiety scores than placebo (Hedges' g = 1.03) but the group difference did not reach significance (p = .056).
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 potential additional applications for autism-related anxiety and alcohol use disorder.
Oncology Providers' Perspectives on Psychedelic-Assisted Therapy. 2026 cross-sectional survey 385 Opposes 80% of oncology providers did not feel comfortable counseling patients on psychedelic-assisted therapy, and only 44% were familiar with its legal status.
Changes in trauma symptoms of discrimination after MDMA-assisted psychotherapy for posttraumatic stress disorder. 2026 preliminary study 5 Supports MDMA-assisted therapy was associated with a 38% reduction in discrimination-related trauma symptoms with a large effect size, in a very small sample.
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 Supports Most of 24 studies reported reduced PTSD symptoms after MDMA-assisted psychotherapy, but no studies directly assessed complex PTSD or borderline personality disorder.
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 and higher rates of clinical response and loss of diagnosis; ketamine and cannabidiol did not show clear benefit.
From therapeutic promise to evidentiary discipline: Reassessing MDMA-assisted psychotherapy for posttraumatic stress disorder. 2026 commentary Mixed Argues that blinding difficulties, expectancy effects, absent active comparators, and limited safety monitoring are central to interpreting MDMA-assisted psychotherapy evidence, and that broader recovery outcomes 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, while noting empirical evidence remains limited.
Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study. 2026 tool development (Delphi) 12 Supports Expert consensus produced a 165-item tool (M-SET) to systematically assess side effects of MDMA-assisted psychotherapy.
State of the Science: MDMA‐assisted psychotherapy for the treatment of posttraumatic stress disorder 2026 review Mixed Reports promising response and remission rates in randomized trials but notes the FDA declined approval in August 2024 due to insufficient evidence, citing blinding, comparator, safety-monitoring, and generalizability limitations.
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 emphasized expectation management, comprehensive screening, consent, therapeutic alliance, integrated care, and provider training as key to MDMA-assisted psychotherapy for PTSD.
Placebo Effects in the Treatment of Depression-Implications for the Psychedelic Renaissance. 2026 review Unclear Argues that expectancy, therapeutic setting, and trial design shape placebo effects in depression trials and are particularly relevant to evaluating psychedelic-like compounds.

Points of agreement

  • Multiple randomized trials report larger PTSD symptom reductions with active MDMA doses than with placebo or low-dose controls.
  • Clinical response and loss of PTSD diagnosis are common in MDMA-treated groups, with gains often maintained at 12-month or longer follow-up.
  • Serious adverse events are rarely reported; MDMA is generally described as well tolerated in trial settings.
  • Pooled and review evidence supports a moderate-to-large effect size for PTSD, larger than conventional pharmacotherapy.
  • Commentators and reviewers agree that blinding, expectancy, and lack of active comparators limit interpretation.

Conflicts

  • Some trials report statistically significant clinician-rated PTSD improvement while others (smaller pilots) show only self-reported significance or per-protocol significance.
  • Reviews describe large effects and breakthrough designation, while others note the FDA declined approval for insufficient evidence.
  • Anxiety in life-threatening illness showed a large but non-significant group difference, contrasting with significant PTSD findings.

Gaps

  • Small sample sizes across most trials, with several pilots under 30 participants.
  • Blinding integrity and expectancy effects are unresolved and rarely quantified.
  • Few active comparator or head-to-head trials against established trauma-focused therapies.
  • Limited data on complex PTSD, borderline personality disorder, and Cluster B disorders.
  • Long-term durability beyond 12 months and relapse rates are sparsely documented.
  • Safety monitoring is not standardized; a side-effect tool was only recently developed.
Browse these studies in the library

Common questions

What does the research agree on about MDMA and psychedelic-assisted therapy?
  • Multiple randomized trials report larger PTSD symptom reductions with active MDMA doses than with placebo or low-dose controls.
  • Clinical response and loss of PTSD diagnosis are common in MDMA-treated groups, with gains often maintained at 12-month or longer follow-up.
  • Serious adverse events are rarely reported; MDMA is generally described as well tolerated in trial settings.
  • Pooled and review evidence supports a moderate-to-large effect size for PTSD, larger than conventional pharmacotherapy.
  • Commentators and reviewers agree that blinding, expectancy, and lack of active comparators limit interpretation.
Where do studies on MDMA and psychedelic-assisted therapy conflict?
  • Some trials report statistically significant clinician-rated PTSD improvement while others (smaller pilots) show only self-reported significance or per-protocol significance.
  • Reviews describe large effects and breakthrough designation, while others note the FDA declined approval for insufficient evidence.
  • Anxiety in life-threatening illness showed a large but non-significant group difference, contrasting with significant PTSD findings.
What is still unknown about MDMA and psychedelic-assisted therapy?
  • Small sample sizes across most trials, with several pilots under 30 participants.
  • Blinding integrity and expectancy effects are unresolved and rarely quantified.
  • Few active comparator or head-to-head trials against established trauma-focused therapies.
  • Limited data on complex PTSD, borderline personality disorder, and Cluster B disorders.
  • Long-term durability beyond 12 months and relapse rates are sparsely documented.
  • Safety monitoring is not standardized; a side-effect tool was only recently developed.
How we analyze this

This synthesis reads the 15 most-cited and 10 most recent studies whose primary subject is MDMA and psychedelic-assisted therapy, up to 25 in all. The most-cited set anchors the established evidence, and the recent set surfaces work that is too new to have gathered citations yet.

A study qualifies only when MDMA and psychedelic-assisted therapy or a known alias appears in its title or keywords, so broad reviews that mention it only in passing are left out. Each study is read from its abstract, strongest evidence first, and the summary reports the direction of the results along with any conflicts and gaps.

The full method, including what a person does and does not review, is on the methods page.

Ask your own question in the Research Synthesis Tool

148 articles · 41 from the last two years · 7,616 participants across 60 studies reporting sample size

Common study designs

review 40 qualitative study 11 systematic review 9 randomized controlled trial 9 theoretical or philosophical paper 16

Research volume by year

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144 studies whose primary subject is MDMA and psychedelic-assisted therapy since 2007

Studies about MDMA and psychedelic-assisted therapy per year, 2007 to 2026, peaking at 28 in 2024 Bar chart: one bar per year, taller where more studies were published that year. 0 15 30 2010 2015 2020 2025
2026 is partial
Show the numbers
Studies about MDMA and psychedelic-assisted therapy per year, 2007 to 2026, peaking at 28 in 2024
Year Studies
2007 1
2008 1
2009 0
2010 1
2011 0
2012 1
2013 1
2014 0
2015 1
2016 3
2017 2
2018 9
2019 7
2020 10
2021 13
2022 14
2023 15
2024 28
2025 23
2026 14

Research

Synthesize the evidence →

From Acute MDMA Experiences to Lasting Change: Self-Compassion’s Role in MDMA-Assisted Psychotherapy for Social Anxiety Disorder

October 25, 2026 Christina Chwyl, Mary K. Lear, Sunjeev K. Kamboj et al. preprint

Objectives: Self-compassion may benefit individuals with social anxiety disorder and serve as a mechanism of change within 3,4-Methylenedioxymethamphetamine (MDMA)-assisted therapy (MDMA-AT). Methods: In this secondary analysis of 20 adults with social anxiety disorder who underwent MDMA-AT for social anxiety disorder (NCT05138068), we examined whether both trait self-compassion changes across...

DOI: 10.31234/osf.io/3ard8_v1 (opens in new tab)

Oncology Providers' Perspectives on Psychedelic-Assisted Therapy.

The American journal of hospice & palliative care August 28, 2026 Krishna Hanubal, Akul Munjal, Jino Park et al.

PurposeDespite most psychedelic substances remaining Schedule I, clinical research exploring psychedelic-assisted therapy (PAT) in oncology is expanding. We sought to assess oncology providers' attitudes toward and understanding of PAT.MethodsWe conducted a cross-sectional survey of healthcare professionals involved in oncology across five academic institutions in California, South Carolina,...

DOI: 10.1177/10499091261483604 (opens in new tab) Full text (opens in new tab) MDMA Ketamine Psilocybin Antidepressants +4

Changes in trauma symptoms of discrimination after MDMA-assisted psychotherapy for posttraumatic stress disorder.

Scientific Reports July 11, 2026 Monnica T. Williams, Sonya C. Faber, Jordan Sloshower et al.

This preliminary study explored the effects of MDMA-assisted therapy on trauma symptoms related to discrimination, as measured by the Trauma Symptoms of Discrimination Scale (TSDS). A total of five diverse participants, who experienced multiple types of discrimination (e.g., gender, racial/ethnic, social class, age, sexual orientation), were assessed before and after treatment. A paired-samples...

DOI: 10.1038/s41598-026-59333-w (opens in new tab) Full text (opens in new tab) MDMA Discrimination Oppression Trauma

Making a case for using MDMA-assisted psychotherapy for borderline personality disorder and complex PTSD: a descriptive systematic review of the literature

Therapeutic Advances in Psychopharmacology July 1, 2026 Karthika Kasiviswanathan, Dinuli Nilaweera, M Morando et al.

Background: 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy (MDMA-AP) has demonstrated considerable efficacy in treating post-traumatic stress disorder (PTSD). PTSD and complex PTSD (CPTSD) frequently co-occur with borderline personality disorder (BPD), a complex disorder marked by emotional dysregulation, interpersonal difficulties and abandonment fears - often accompanied by...

DOI: 10.1177/20451253251408626 (opens in new tab) Ecstasy Borderline personality disorder Psycinfo Abandonment legal +10

Psychedelic-Assisted Psychotherapy for the Treatment of PTSD: A Systematic Review and Meta-Analysis

Psychoactives June 8, 2026 Fizza Mitter, Anton Sheptooha, Janni Leung et al.

Post-traumatic stress disorder (PTSD) remains inadequately treated by existing pharmacological and psychological interventions, prompting growing interest in psychedelic-assisted psychotherapy. Although randomised controlled trials have evaluated several psychedelic agents for PTSD, to our knowledge, no prior PTSD-specific synthesis has quantitatively examined multiple agent classes within a...

DOI: 10.3390/psychoactives5020016 (opens in new tab) MDMA Cannabidiol Systematic review Randomized controlled trial +7

MDMA-Assisted Psychotherapy for Cluster B Personality Disorders: A Narrative Review of This Translational Framework for Relational Healing

European Psychiatry June 1, 2026 M. Rocha, V. Sharma, S. Prasad et al.

Introduction Psychedelic-assisted psychotherapy has re-emerged as a frontier of psychiatry, offering transformative potential for conditions resistant to conventional treatment. Personality disorders—particularly Borderline Personality Disorder (BPD)—are marked by affective instability, interpersonal dysfunction, and maladaptive relational patterns that often limit therapeutic progress. MDMA’s...

DOI: 10.1192/j.eurpsy.2026.11914 (opens in new tab) Full text (opens in new tab) Borderline personality disorder Openness to experience Interpersonal communication Narrative review +13

From therapeutic promise to evidentiary discipline: Reassessing MDMA-assisted psychotherapy for posttraumatic stress disorder.

Journal of Traumatic Stress June 1, 2026 Kadek Suhardita, Veno Dwi Krisnanda, Rikas Saputra et al.

In this commentary on Morland et al. (2026)'s recent State of the Science article on 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for posttraumatic stress disorder (PTSD), we aim to emphasize both MDMA's therapeutic promise and its unresolved scientific challenges. Although recent trials on MDMA-assisted interventions have reported encouraging reductions in PTSD symptoms, the...

DOI: 10.1002/jts.70094 (opens in new tab) Full text (opens in new tab)

Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study.

BMJ Open May 11, 2026 Julia Colcott, Alexandre A. Guerin, Olivia Carter et al.

Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists. Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP. Informed by a systematic review and a review of other...

DOI: 10.1136/bmjopen-2025-105630 (opens in new tab) Full text (opens in new tab) Adult psychiatry Adverse events

State of the Science: MDMA‐assisted psychotherapy for the treatment of posttraumatic stress disorder

Journal of Traumatic Stress March 12, 2026 Leslie A. Morland, Barbara O Rothbaum, Lauren M. Sippel et al. 2 citations

There is growing interest in novel approaches to treating posttraumatic stress disorder (PTSD), including the use of psychedelic substances combined with psychotherapy, often referred to as psychedelic-assisted therapy, to better meet the needs of patients who do not prefer or respond to traditional evidence-based treatments. Among these treatments, 3,4-methylenedioxymethamphetamine...

DOI: 10.1002/jts.70060 (opens in new tab) Posttraumatic stress Cognition Cognitive behavioral therapy Leverage statistics +9

Experiences of Australian clinicians, researchers, and patients with MDMA-assisted psychotherapy for post-traumatic stress disorder: A framework-guided qualitative analysis.

Journal of Affective Disorders February 2, 2026 Alene Sze Jing Yong, Aimee Freeburn, Suzie Bratuskins et al.

Australia recently became the first country to reschedule methylenedioxymethamphetamine (MDMA) to permit authorized prescribing for post-traumatic stress disorder (PTSD) outside of clinical trials. This study explored the direct experience of Australian clinicians, researchers, and patients regarding the use of MDMA-assisted psychotherapy (MDMA-AP) for PTSD to inform guideline development....

DOI: 10.1016/j.jad.2026.121276 (opens in new tab) Full text (opens in new tab)

Clinical trials

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