Evidence map›Paper›PMID 32500209›Full record

Trial reportPsychopharmacology2020

Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.

Lisa Jerome, Allison A Feduccia, Julie B Wang, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C Mithoefer, Rick Doblin

Retracted 7 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled TrialRetracted Publication
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Psychopharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to 7 registered trials, which are not on this map. Cited by 69 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 7 pooled it
9.6field-weighted citation impact, top 2% 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.

NCT00090064 phase2completednot on this map

Phase II Clinical Trial Testing the Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in Subjects With Chronic Posttraumatic Stress Disorder

TypeinterventionalSponsorResilient PharmaceuticalsRan2004 to 2010Enrolled23ConditionsPosttraumatic Stress DisorderArmsMidomafetamine HCl, Lactose placebo pill, Therapy
NCT00353938 phase2completednot on this map

Phase II Pilot Randomized Double-Blind Placebo-Controlled Study of 3,4-methylenedioxymethamphetamine (MDMA)Assisted Psychotherapy in Posttraumatic Stress Disorder (PTSD)- Switzerland

TypeinterventionalSponsorResilient PharmaceuticalsRan2006 to 2011Enrolled14ConditionsPosttraumatic Stress DisorderArms3,4-methylenedioxymethamphetamine (125 mg), 3,4-methyelendioxymethamphetamine (25 mg), Therapy
NCT01211405 phase2completednot on this map

Randomized, Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction With Manualized Therapy in 24 Veterans, Firefighters and Police Officers With Chronic Posttraumatic Stress Disorder (PTSD)

TypeinterventionalSponsorResilient PharmaceuticalsRan2010 to 2016Enrolled26ConditionsPosttraumatic Stress DisorderArmsLow dose MDMA-assisted therapy, Medium dose MDMA-assisted therapy, Full dose MDMA-assisted therapy, Therapy
NCT01689740 phase2completednot on this map

A Randomized, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-assisted Psychotherapy in People With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

TypeinterventionalSponsorResilient PharmaceuticalsRan2013 to 2017Enrolled10ConditionsPosttraumatic Stress Disorder (PTSD)ArmsActive Placebo Dose MDMA-assisted therapy (25 mg), Full Dose MDMA-assisted therapy (125 mg), Open-Label Full Dose MDMA-assisted therapy (125 mg), Psychotherapy
NCT01793610 phase2completednot on this map

A Randomized, Double-Blind, Dose Response Phase 2 Pilot Study of Manualized MDMA-Assisted Psychotherapy in Subjects With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

TypeinterventionalSponsorResilient PharmaceuticalsRan2013 to 2017Enrolled29ConditionsPosttraumatic Stress DisorderArmsComparator Dose (40mg) MDMA HCl, Active Dose 2 (100 mg) MDMA HCl, Active Dose 1 (125 mg) MDMA HCl, Psychotherapy
NCT01958593 phase2terminatednot on this map

A Randomized, Double-Blind, Controlled Phase 2 Pilot Study of Manualized 3,4-methylenedioxymethamphetamine (MDMA)-Assisted Psychotherapy in 12 Subjects With Treatment-Resistant Posttraumatic Stress Disorder (PTSD) - Canada

TypeinterventionalSponsorResilient PharmaceuticalsRan2014 to 2016Enrolled6ConditionsPosttraumatic Stress DisorderArmsPlacebo, Midomafetamine HCl, Psychotherapy
NCT04965740 completednot on this mapstarted 2021, after this paper: background citation

EMPOWER Study: Exploring Medically Perceived Benefits, Use and Interest in Psychedelics and Cannabinoids: Observational Study With First Responders and Military Personnel Examining Previous Use Experience and Interest in Participating in Future Research Studies

TypeobservationalSponsorEmpower Research IncRan2021 to 2022Enrolled102ConditionsPTSD, Anxiety, Anxiety Disorders, DepressionArmsCannabis
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 7 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Review
  15. Informed Consent in Psychedelic-Assisted Therapy.Current topics in behavioral neurosciences · 2026
    Review
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  17. Review
  18. Review
  19. Review
  20. Article

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Lisa JeromeMAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA. Ilsa@mapsbcorp.com.ORCID http://orcid.org/0000-0001-6209-8750
Allison A FeducciaMAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
Julie B WangMAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
Scott HamiltonStanford School of Medicine, Stanford University, Stanford, CA, USA.
Berra Yazar-KlosinskiMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
Amy EmersonMAPS Public Benefit Corporations, 1115 Mission St., Santa Cruz, CA, 95060, USA.
Michael C MithoeferMedical University of South Carolina, Charleston, SC, USA.
Rick DoblinMultidisciplinary Association for Psychedelic Studies, Santa Cruz, CA, USA.
Public Service Electric and Gas (United States) · USMultidisciplinary Association for Psychedelic Studies · USMedical University of South Carolina · USStanford University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationalePosttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD.

objectivesTo examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD.

methodsParticipants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire.

resultsThere was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation.

conclusionsPTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.

trial registrationclinicaltrials.gov Identifier: NCT00090064, NCT00353938, NCT01958593, NCT01211405, NCT01689740, NCT01793610.

Indexed as

AdultCombined Modality TherapyCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansLongitudinal StudiesMaleMiddle AgedN-Methyl-3,4-methylenedioxyamphetaminePsychotherapyStress Disorders, Post-TraumaticSurveys and QuestionnairesTreatment OutcomeN-Methyl-3,4-methylenedioxyamphetamineLong-term follow-upMDMAMDMA-assisted psychotherapyPTSD

Identifiers

PMID32500209
PMCPMC7351848
OpenAlexW3033913667

What OpenQuestion holds

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Registered trials

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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.