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

This double-blind, placebo-controlled, randomized pilot study (n=12) found a significant reduction in social anxiety (d=1.4) after MDMA-assisted psychotherapy (75-125mg, 2 sessions). The effects persisted even 6-months later (d=1.1).

Abstract

Rationale: Standard 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.

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

Methods: Autistic 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.

Results: Improvement in LSAS scores from baseline to the primary endpoint was significantly greater for the 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.

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

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

Notes

This paper builds on the earlier review work by Danforth et al. (2016).

Study details

Compounds studied
MDMA

Topics studied
Autism Anxiety

Study characteristics
Original Placebo-Controlled Double-Blind Randomized

Participants
12 Humans

Authors

Authors associated with this publication with profiles on Blossom

Alicia Danforth
Alicia Danforth is a clinical psychologist who specializes in psychotherapy for autistic adults (private practice). Next to this she also works on several clinical studies and provides integration work.

Charles Grob
Charles Grob is a Professor of Psychiatry & Biobehavioral Sciences and Pediatrics at UCLA. His work with MDMA was the first FDA approved Phase 1 study. He co-founded the Heffter Research Institute and is also affiliated with the Lundquist Institute for Biomedical Innovation.

Institutes

Institutes associated with this publication

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Compound Details

The psychedelics given at which dose and how many times

MDMA 75 - 125
mg | 2x

Linked Research Papers

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MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults
This overview/review paper lays the groundwork for offering MDMA-assisted psychotherapy for the treatment of social anxiety in autistic adults.

Linked Clinical Trial

Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults
This double-blind, randomized, placebo-controlled exploratory pilot study assessed the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for social anxiety in MDMA-naïve adults on the autism spectrum.