A Placebo-Controlled, Randomized, Blinded, Dose Finding Phase 2 Pilot Safety Study of MDMA-Assisted Therapy for Social Anxiety in Autistic Adults (MAA-1)

Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study

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.”

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 sponsored 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. This study was also designed to obtain estimates of effect size based on two experimental MDMA-assisted therapy sessions in comparison to an inactive placebo control group. Participants were randomized to receive either MDMA (75 to 125 mg) or inactive placebo during two 8-hour therapy sessions. 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 five months later.

Results showed an improvement in LSAS scores at the primary endpoint that was significantly greater for the MDMA group than the placebo group (p=0.037). Six month follow-up scores showed similar positive results, with a reduction in LSAS scores that was still statistically significant (p=0.036).