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.

Each of the 12 subjects participated in two blinded experimental sessions, assisted by either MDMA (75 mg to 125 mg) or placebo, which lasted seven hours. Before experimental sessions, participants underwent three separate hour-long preparatory sessions to learn what to expect and complete pre-treatment assignments. After each experimental session, participants underwent three separate hour-long integrative sessions to help integrate their experiences and insights from the experimental sessions.

Subjects assigned to the MDMA group received two of three different doses, either 75 mg, 100 mg, or 125 mg MDMA. Overall, eight subjects were randomized to the MDMA group and four subjects were randomized to the placebo group. Observations before, during, and after experimental sessions were compared between these groups.

The main objective of this study was to collect safety data to examine whether MDMA-assisted therapy was tolerated and to estimate symptom reduction in social anxiety and other psychiatric symptoms. The primary outcome measure was change in social anxiety symptoms as measured by the Liebowitz Social Anxiety Scale (LSAS)

Topic Anxiety Autism
Compound Placebo MDMA
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

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.

Lundquist Institute
The Lundquist Institute for Biomedical Innovation is an independent non-profit biomedical research organization that was founded in 1952. It supports more than 100 research groups which includes work being done by Charles Grob.

Papers

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).

Data attribution

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