Autism refers to a spectrum of congenital pervasive developmental disabilities. Comparative studies suggest that autistic adults are at greater risk for lifetime and current co-morbid mood and anxiety disorders, especially social anxiety. Autistic adults who are verbal and whose autism might not be immediately recognizable to others often initially present in a clinical setting with a co-morbid diagnosis of anxiety or depression. Social anxiety is characterized by fear of scrutiny and avoidance of social interactions and frequently compounds the considerable social challenges experienced by autistic adults.
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 proposing 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.
Charles Grob, M.D., and Alicia Danforth, Ph.D.©, will be co-investigators for this study.
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
April 30, 2013: Protocol design approved by the U.S. Food and Drug Administration
- Download the protocol for this study
- View the protocol synopsis
- View the April 20, 2013 Advice Letter from the FDA
$256,000 estimated study cost / $256,000 still needed