Cited by 674Psychedelics and Drug StudiesPosttraumatic Stress Disorder ResearchElectroconvulsive Therapy Studies

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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

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Mithoefer, Michael C, Wagner, Mark T, Mithoefer, Ann T, Jerome, Lisa, Doblin, Rick·2011·Journal of Psychopharmacology

DOI 10.1177/0269881110378371PMC PMC3122379

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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.

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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
ORCID: Mithoefer, Michael C
Jerome, Lisa
Doblin, Rick
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
DOI: 10.1177/0269881110378371
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
Licence: cc-by-nc
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
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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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

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