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MAPS Bulletin Summer 2014: Research Edition
Research > MDMA-Assisted Psychotherapy

MDMA-Assisted Therapy for the Treatment of Social Anxiety in Autistic Adults

Learn more at mdma-autism.org.

Autism is a genetically based human neurological variant. Autism is a developmental phenomenon, meaning that it begins in utero and has a pervasive influence on multiple levels of development throughout the lifespan. Autistic individuals frequently experience difficulty in the realm of social interaction. Comparative studies suggest that autistic adults, especially those who are verbal and whose autism might not be immediately recognizable to others and who are faced with strong pressure to conform to non-autistic social norms, are at greater risk for lifetime and current psychological disorders, especially social anxiety.

There are currently no FDA-approved pharmacological treatments for autistic adults with social anxiety, and conventional anti-anxiety medications lack clinical effectiveness in this population. Based on anecdotal reports, MDMA-assisted therapy may be a suitable intervention for the treatment of social anxiety in autistic adults and warrants further investigation in a randomized controlled clinical trial.

MAPS 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 MDMA-naïve adults on the autism spectrum. This study will also 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.

In affiliation with

Charles Grob, M.D., and Alicia Danforth, Ph.D.(c), will be co-investigators for this study.

MAPS is sponsoring this collaborative study between the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and Stanford University.

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.

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

$320,000 estimated study cost • $1,000 raised + $15,000 raised by partners • $304,000 still needed

Please consider donating today to help complete this study.

View the complete timeline for this study.

Learn more at mdma-autism.org.

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