Trial reportJournal of psychopharmacology (Oxford, England)2011
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.
Trial report in Journal of psychopharmacology (Oxford, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 228 papers, 17 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder
The Effects of MDMA on Prefrontal and Amygdala Activation in Posttraumatic Stress Disorder
A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD
Who cites it
228 citing papers in PubMed, 17 syntheses or guidelines pooled it, 659 citations in OpenAlex.
- Magnitude of response in treatment and control groups within psychedelic trials for psychiatric disorders: A meta-analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2026Pooled it
- Reconsidering evidence for psychedelic-induced psychosis: an overview of reviews, a systematic review, and meta-analysis of human studies.Molecular psychiatry · 2025Pooled it
- Pooled it
- MDMA-assisted psychotherapy for the treatment of PTSD: A systematic review and meta-analysis of randomized controlled trials (RCTs).Neuropsychopharmacology reports · 2024Pooled it
- Comparative oral monotherapy of psilocybin, lysergic acid diethylamide, 3,4-methylenedioxymethamphetamine, ayahuasca, and escitalopram for depressive symptoms: systematic review and Bayesian network meta-analysis.BMJ (Clinical research ed.) · 2024Pooled it
- Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024Pooled it
- In the new era of psychedelic assisted therapy: A systematic review of study methodology in randomized controlled trials.Psychopharmacology · 2024Pooled it
- Functional brain changes after alternative pharmacological interventions in posttraumatic stress disorder: A systematic review of clinical trials.Brain and behavior · 2023Pooled it
- The Impact of Posttraumatic Stress Disorder on Pharmacologic Intervention Outcomes for Adults With Bipolar Disorder: A Systematic Review.The international journal of neuropsychopharmacology · 2023Pooled it
- Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review.Journal of psychopharmacology (Oxford, England) · 2022Pooled it
- Drug-drug interactions between psychiatric medications and MDMA or psilocybin: a systematic review.Psychopharmacology · 2022Pooled it
- MDMA and memory, addiction, and depression: dose-effect analysis.Psychopharmacology · 2022Pooled it
- Psychedelic-Assisted Psychotherapy-A Systematic Review of Associated Psychological Interventions.Frontiers in psychology · 2022Pooled it
- Interventions for adults with a history of complex traumatic events: the INCiTE mixed-methods systematic review.Health technology assessment (Winchester, England) · 2020Pooled it
- Psychedelic Treatments for Psychiatric Disorders: A Systematic Review and Thematic Synthesis of Patient Experiences in Qualitative Studies.CNS drugs · 2020Pooled it
- Cognitive Effects of MDMA in Laboratory Animals: A Systematic Review Focusing on Dose.Pharmacological reviews · 2019Pooled it
- A translational perspective on neural circuits of fear extinction: Current promises and challenges.Neurobiology of learning and memory · 2018Pooled it
- Comparison of acute effects of 3,4-methylenedioxymethamphetamine (MDMA) with and without a supplemental booster dose in healthy participants: a double-blind, randomized, placebo-controlled, crossover study.Translational psychiatry · 2026Trial
- Preliminary evidence for the importance of therapeutic alliance in MDMA-assisted psychotherapy for posttraumatic stress disorder.European journal of psychotraumatology · 2024Trial
- Evaluating the attitudes of mental health professionals towards trials of MDMA: a randomised vignette trial.BMJ open · 2022Trial
168 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Case reports indicate that psychiatrists administered ±3,4-methylenedioxymethamphetamine (MDMA) as a catalyst to psychotherapy before recreational use of MDMA as 'Ecstasy' resulted in its criminalization in 1985. Over two decades later, this study is the first completed clinical trial evaluating MDMA as a therapeutic adjunct. Twenty patients with chronic posttraumatic stress disorder, refractory to both psychotherapy and psychopharmacology, were randomly assigned to psychotherapy with concomitant active drug (n = 12) or inactive placebo (n = 8) administered during two 8-h experimental psychotherapy sessions. Both groups received preparatory and follow-up non-drug psychotherapy. The primary outcome measure was the Clinician-Administered PTSD Scale, administered at baseline, 4 days after each experimental session, and 2 months after the second session. Neurocognitive testing, blood pressure, and temperature monitoring were performed. After 2-month follow-up, placebo subjects were offered the option to re-enroll in the experimental procedure with open-label MDMA. Decrease in Clinician-Administered PTSD Scale scores from baseline was significantly greater for the group that received MDMA than for the placebo group at all three time points after baseline. The rate of clinical response was 10/12 (83%) in the active treatment group versus 2/8 (25%) in the placebo group. There were no drug-related serious adverse events, adverse neurocognitive effects or clinically significant blood pressure increases. MDMA-assisted psychotherapy can be administered to posttraumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory to other treatments.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.