MDMA-Assisted Therapy for Social Anxiety in Autistic Adults

An exploratory pilot study

Based on the known effects of MDMA, as well as individual reports, researchers are developing a clinical study into the safety and effectiveness of MDMA-assisted therapy for the treatment of social anxiety in 12 MDMA-naïve adults on the autism spectrum.

The goal of this study is to determine if MDMA-assisted therapy can safely and effectively enhance functional skills in autistic adults, an underserved group which tends to experience greater anxiety, depression and victimization than typically developing (TD) adults.

MAPS, a not-for-profit research organization, is sponsoring a randomized, double-blind, placebo-controlled exploratory pilot study with dose escalation to assess the safety and feasibility of MDMA-assisted therapy to treat social anxiety in 12 adults on the autism spectrum with no prior MDMA experience.

Clinical Investigators: Charles Grob, M.D., and Alicia Danforth, Ph.D.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is sponsoring this collaborative study between the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and Stanford University.

About the protocol

This study will obtain estimates of effect size based on two experimental MDMA-assisted therapy sessions in comparison to an inactive placebo control group. If the results warrant further investigation, data from this study will be used to design additional studies.

Subjects will be autistic adults with social anxiety, age 21 and older, who have completed two years of college-level education or comparable vocational training.

Download the study protocol

View on clinicaltrials.gov

Study timeline

February 28, 2013: Protocol submitted for review by the U.S. Food and Drug Administration
July 18, 2013: Protocol approved by the U.S. Food and Drug Administration
October 16, 2013: Protocol approved by the Institutional Review Board
December 27, 2013: Schedule I license approved by the U.S. Drug Enforcement Administration
February 10, 2014: Site initiation visit completed
April 4, 2014: Subject screening begun
August 9, 2014: First subject treated
October 29, 2016: 12th and final subject received their last blinded experimental session

Funding needs

$400,000 estimated study cost • $13,000 raised + $15,000 raised by partners • $372,000 still needed

Principal Investigator

Charles S. Grob, M.D., is Director of the Division of Child and Adolescent Psychiatry at Harbor-UCLA Medical Center, and Professor of Psychiatry and Pediatrics at the University of California, Los Angeles School of Medicine.

Co-Investigator

Alicia Danforth, Ph.D., is a research associate at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center.

In affiliation with

Featured Article

MDMA-Assisted Therapy:
A New Treatment Model for Social Anxiety in Autistic Adults

by Alicia L. Danforth, Christopher M. Struble, Berra Yazar-Klosinski, Charles S. Grob

We need your support to complete this study

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a 501(c)(3) non-profit research and educational organization.

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