Evidence map›Paper›PMID 30196397›Full record

Trial reportPsychopharmacology2018

Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study.

Alicia L Danforth, Charles S Grob, Christopher Struble, Allison A Feduccia, Nick Walker, Lisa Jerome, Berra Yazar-Klosinski, Amy Emerson

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

Trial report in Psychopharmacology, 2018. 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 108 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 13 pooled it
11.9field-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.

NCT02008396 phase2completednot on this map

A Placebo-controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults

TypeinterventionalSponsorResilient PharmaceuticalsRan2014 to 2017Enrolled12ConditionsSocial Anxiety in Autistic AdultsArmsPlacebo, Midomafetamine HCl, Therapy
NCT05138068 phase2completednot on this mapstarted 2022, after this paper: background citation

Social Anxiety MDMA-Assisted Therapy Investigation (SAMATI): A Randomized, Delayed Treatment Control Phase 2 Study of the Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Social Anxiety Disorder

TypeinterventionalSponsorJason B LuomaRan2022 to 2025Enrolled90ConditionsSocial Anxiety DisorderArmsMDMA, Psychotherapy
3 · Its place in the literature

Who cites it

108 citing papers in PubMed, 13 syntheses or guidelines pooled it, 276 citations in OpenAlex.

  1. Pooled it
  2. Autism, youth suicide, and psychedelics: A review of the 21st century evidence.Journal of the Chinese Medical Association : JCMA · 2024
    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
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  14. Trial
  15. Endocannabinoid contributions to the perception of socially relevant, affective touch in humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025
    Trial
  16. Trial
  17. MDMA enhances positive affective responses to social feedback.Journal of psychopharmacology (Oxford, England) · 2024
    Trial
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  19. Effects of MDMA on attention to positive social cues and pleasantness of affective touch.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2019
    Trial
  20. Review

48 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

8 authors at 5 institutions in 1 country.

Alicia L DanforthLos Angeles Biomedical Research Institute, Harbor-UCLA Medical Center, Box 498, 1000 West Carson Blvd., Torrance, CA, 90509, USA.
Charles S GrobDepartment of Psychiatry, Harbor-UCLA Medical Center, Box 498, 1000 West Carson Blvd., Torrance, CA, 90509, USA. cgrob@labiomed.org.
Christopher StrubleDepartment of Psychiatry, Harbor-UCLA Medical Center, Box 498, 1000 West Carson Blvd., Torrance, CA, 90509, USA.
Allison A FeducciaMAPS Public Benefit Corporation, 1115 Mission Street, Santa Cruz, CA, 95060, USA.
Nick WalkerSchool of Undergraduate Studies, California Institute of Integral Studies, 1453 Mission Street, San Francisco, CA, 94103, USA.
Lisa JeromeMAPS Public Benefit Corporation, 1115 Mission Street, Santa Cruz, CA, 95060, USA.
Berra Yazar-KlosinskiMultidisciplinary Association for Psychedelic Studies, 1115 Mission Street, Santa Cruz, CA, 95060, USA.
Amy EmersonMAPS Public Benefit Corporation, 1115 Mission Street, Santa Cruz, CA, 95060, USA.
Public Service Electric and Gas (United States) · USHarbor–UCLA Medical Center · USCalifornia Institute of Integral Studies · USMultidisciplinary Association for Psychedelic Studies · USThe Lundquist Institute · US

Funding

Multidisciplinary Association for Psychedelic Studies NA
6 · The paper itself

Abstract

rationaleStandard therapeutic approaches to reduce social anxiety in autistic adults have limited effectiveness. Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatment for other anxiety disorders, a blinded, placebo-controlled pilot study was conducted.

objectivesTo explore feasibility and safety of MDMA-assisted psychotherapy for reduction of social fear and avoidance that are common in the autistic population.

methodsAutistic adults with marked to very severe social anxiety were randomized to receive MDMA (75 to 125 mg, n = 8) or inactive placebo (0 mg, n = 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting. Double-blinded experimental sessions were spaced approximately 1 month apart with 3 non-drug psychotherapy sessions following each. The primary outcome was change in Leibowitz Social Anxiety Scale (LSAS) Total scores from Baseline to one month after the second experimental session. Outcomes were measured again six months after the last experimental session.

resultsImprovement in LSAS scores from baseline to the primary endpoint was significantly greater for MDMA group compared to the placebo group (P = 0.037), and placebo-subtracted Cohen's d effect size was very large (d = 1.4, CI - 0.074, 2.874). Change in LSAS scores from baseline to 6-month follow-up showed similar positive results (P = 0.036), with a Cohen's d effect size of 1.1 (CI - 0.307, 2.527). Social anxiety remained the same or continued to improve slightly for most participants in the MDMA group after completing the active treatment phase.

conclusionsThis pilot trial demonstrated rapid and durable improvement in social anxiety symptoms in autistic adults following MDMA-assisted psychotherapy. Initial safety and efficacy outcomes support expansion of research into larger samples to further investigate this novel treatment for social anxiety.

trial registrationclinicaltrials.gov identifier, NCT02008396.

Indexed as

AdultAnxietyAutistic DisorderCombined Modality TherapyDouble-Blind MethodFearFemaleHumansMaleMiddle AgedN-Methyl-3,4-methylenedioxyamphetaminePilot ProjectsPsychotherapySerotonin AgentsTreatment OutcomeN-Methyl-3,4-methylenedioxyamphetamineSerotonin Agents3,4-MethylenedioxymethamphetamineAnxietyAsperger’sAutismLiebowitz Social Anxiety ScaleMDMAMDMA-assisted psychotherapyPsychedelicsSocial anxiety

Identifiers

PMID30196397
PMCPMC6208958
OpenAlexW2892030583

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.