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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
Open accessAbstract
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.
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“MDMA’s softening of rigid self-protective mechanisms reduces interpersonal defensiveness, and increases sensitivity to emotional and relational dynamics, allowing for deeper engagement in the therapeutic process (88, 100, 102).”
From Psychoanalytically informed MDMA-assisted therapy for pathological narcissism: a novel theoretical approach (2025) · cites this paper as [102]
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“Several small trials suggest that MDMA-assisted psychother apydoes have a superior effect 148,149 , and large multi-site studies are now underway 150 .”
From Post‐traumatic stress disorder: a state‐of‐the‐art review of evidence and challenges (2019) · cites this paper as [148]
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Metadata
- Authors
- Mithoefer, M. C., Wagner, M. T., Mithoefer, A. T., Jerome, L., & Doblin, R.
- Affiliations
- Private Practice of Psychiatry and Clinical Research, Mount Pleasant SC, USA.
- Medical University of South Carolina (US)
- Multidisciplinary Association for Psychedelic Studies (US)
- Corresponding author
- Mithoefer, Michael C
- Venue
- Journal of Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2010-07-19
- Volume
- 25
- Issue
- 4
- Pages
- 439-452
- ISSN
- 0269-8811 (ISSN-L)
- 1461-7285
- PMC
- PMC3122379
- OpenAlex
- W2089149909
- Cited by
- 674
- References
- 67
- Citations by year
- 2026: 30 · 2025: 36 · 2024: 75 · 2023: 49 · 2022: 52 · 2021: 41 · 2020: 61 · 2019: 62 · 2018: 59 · 2017: 45 · 2016: 28 · 2015: 27 · 2014: 23 · 2013: 44 · 2012: 26
- FWCI
- 29.42
- Type
- journal article
- Language
- en
- Update notices
- correction (2011-06-01)
- Open access
- hybrid
- doi.org
- Locations
- Journal of Psychopharmacology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Social Sciences › Psychology › Clinical Psychology › Posttraumatic Stress Disorder Research
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- MDMA-assisted psychotherapy, MDMA, 3,4-methylenedioxymethamphetamine, post-traumatic stress disorder, treatment-resistant PTSD, chronic PTSD, psychedelic therapy, Clinician-Administered PTSD Scale, adverse events, neurocognitive effects, blood pressure
- MeSH terms
- Adult, Aged, Double-Blind Method, Fear, Female, Humans, Male, Middle Aged, Music Therapy, Pilot Projects, Placebos, Psychiatric Status Rating Scales, Psychotherapy, Stress Disorders, Post-Traumatic, Treatment Outcome, Serotonin Agents, Cross-Over Studies, N-Methyl-3,4-methylenedioxyamphetamine, Young Adult
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