Evidence map›Paper›PMID 23172889›Full record

Trial reportJournal of psychopharmacology (Oxford, England)2013

Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study.

Michael C Mithoefer, Mark T Wagner, Ann T Mithoefer, Lisa Jerome, Scott F Martin, Berra Yazar-Klosinski, Yvonne Michel, Timothy D Brewerton, Rick Doblin

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of psychopharmacology (Oxford, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 151 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 11 pooled it
26.6field-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.

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
NCT03752918 phase1withdrawnnot on this mapstarted 2024, after this paper: background citation

The Effects of MDMA on Prefrontal and Amygdala Activation in Posttraumatic Stress Disorder

TypeinterventionalSponsorYale UniversityRan2024 to 2028Enrolled0ConditionsPost Traumatic Stress DisorderArmsMDMA, Niacin
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 11 syntheses or guidelines pooled it, 370 citations in OpenAlex.

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  17. Effects of MDMA on attention to positive social cues and pleasantness of affective touch.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2019
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91 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

9 authors at 2 institutions in 1 country.

Michael C Mithoefermmithoefer@mac.com
Mark T Wagner
Ann T Mithoefer
Lisa Jerome
Scott F Martin
Berra Yazar-Klosinski
Yvonne Michel
Timothy D Brewerton
Rick Doblin
Multidisciplinary Association for Psychedelic Studies · USMedical University of South Carolina · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report follow-up data evaluating the long-term outcomes for the first completed trial of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for chronic, treatment-resistant post-traumatic stress disorder (PTSD) (Mithoefer et al., 2011). All of the 19 subjects who received MDMA-assisted treatment in the original trial participated in the long-term follow-up (LTFU), with 16 out of 19 completing all of the long-term outcome measures, which were administered from 17 to 74 months after the original study's final MDMA session (mean = 45.4; SD = 17.3). Our primary outcome measure used was the Clinician-Administered PTSD Scale (CAPS). Secondary outcome measures were the Impact of Events Scale-Revised (IES-R) and the Neuroticism Extroversion Oppenness Personality Inventory-Revised (NEO PI-R) Personality Inventory. We also collected a long-term follow-up questionnaire. Results for the 16 CAPS completers showed there were no statistical differences between mean CAPS score at LTFU (mean = 23.7; SD = 22.8) (t (matched) = 0.1; df = 15, p = 0.91) and the mean CAPS score previously obtained at Study Exit (mean = 24.6, SD = 18.6). On average, subjects maintained statistically and clinically-significant gains in symptom relief, although two of these subjects did relapse. It was promising that we found the majority of these subjects with previously severe PTSD who were unresponsive to existing treatments had symptomatic relief provided by MDMA-assisted psychotherapy that persisted over time, with no subjects reporting harm from participation in the study.

Indexed as

AdultFemaleFollow-Up StudiesHumansIllicit DrugsMaleN-Methyl-3,4-methylenedioxyamphetamineOutcome Assessment, Health CareProspective StudiesPsychotherapyStress Disorders, Post-TraumaticSubstance-Related DisordersSurveys and QuestionnairesTreatment OutcomeIllicit DrugsN-Methyl-3,4-methylenedioxyamphetamine

Identifiers

PMID23172889
PMCPMC3573678
OpenAlexW2127654449

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.