Evidence map›Paper›PMID 30371148›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2018

3,4-Methylenedioxymethamphetamine-assisted psychotherapy for treatment of chronic posttraumatic stress disorder: A randomized phase 2 controlled trial.

Marcela Ot'alora G, Jim Grigsby, Bruce Poulter, Joseph W Van Derveer, Sara Gael Giron, Lisa Jerome, Allison A Feduccia, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson and 2 more

Open access · hybridAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 13 pooled it
18.7field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 13 syntheses or guidelines pooled it, 224 citations in OpenAlex.

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  2. 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 · 2026
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  7. Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
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29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Marcela Ot'alora G1 Aguazul-Bluewater, Inc., Boulder, CO, USA.
Jim Grigsby2 Department of Psychology, University of Colorado, Denver, CO, USA.
Bruce Poulter1 Aguazul-Bluewater, Inc., Boulder, CO, USA.
Joseph W Van Derveer3 Integrative Psychiatric Healing Center, Boulder, CO, USA.
Sara Gael Giron4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA.
Lisa Jerome5 MAPS Public Benefit Corporation, Boulder, CO, USA.ORCID 0000-0001-6209-8750
Allison A Feduccia5 MAPS Public Benefit Corporation, Boulder, CO, USA.
Scott Hamilton6 Stanford School of Medicine, Stanford, CA, USA.
Berra Yazar-Klosinski4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA.
Amy Emerson5 MAPS Public Benefit Corporation, Boulder, CO, USA.
Michael C Mithoefer7 Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
Rick Doblin4 Multidisciplinary Association for Psychedelic Studies (MAPS), Boulder, USA.
Multidisciplinary Association for Psychedelic Studies · USPublic Service Electric and Gas (United States) · USBluewater International (United States) · USHealing Institute · USMedical University of South Carolina · USStanford Medicine · USUniversity of Colorado Denver · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPosttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms.

aimsThis pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams.

methodsTwenty-eight people with chronic posttraumatic stress disorder were randomized in a double-blind dose response comparison of two active doses (100 and 125 mg) with a low dose (40 mg) of MDMA administered during eight-hour psychotherapy sessions. Change in the Clinician-Administered PTSD Scale total scores one month after two sessions of MDMA served as the primary outcome. Active dose groups had one additional open-label session; the low dose group crossed over for three open-label active dose sessions. A 12-month follow-up assessment occurred after the final MDMA session.

resultsIn the intent-to-treat set, the active groups had the largest reduction in Clinician-Administered PTSD Scale total scores at the primary endpoint, with mean (standard deviation) changes of -26.3 (29.5) for 125 mg, -24.4 (24.2) for 100 mg, and -11.5 (21.2) for 40 mg, though statistical significance was reached only in the per protocol set ( p=0.03). Posttraumatic stress disorder symptoms remained lower than baseline at 12-month follow-up ( p<0.001) with 76% ( n=25) not meeting posttraumatic stress disorder criteria. There were no drug-related serious adverse events, and the treatment was well-tolerated.

conclusionsOur findings support previous investigations of MDMA-assisted psychotherapy as an innovative, efficacious treatment for posttraumatic stress disorder.

Indexed as

AdultAgedCombined Modality TherapyCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHallucinogensHumansMaleMiddle AgedN-Methyl-3,4-methylenedioxyamphetaminePilot ProjectsPsychiatric Status Rating ScalesPsychotherapyHallucinogensN-Methyl-3,4-methylenedioxyamphetamine3,4-Methylenedioxymethamphetamine (MDMA)depressionoxytocinposttraumatic stress disorderserotoninsleep disturbance

Identifiers

PMID30371148
PMCPMC6247454
OpenAlexW2899027265

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.