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.
Details
Randomized, triple-masked, parallel-group Phase II pilot (n=12) comparing two blinded MDMA-assisted therapy sessions to two blinded placebo-with-therapy sessions in autistic adults with social anxiety; therapy included three 1-h preparatory sessions and three 1-h integrative sessions after each experimental session.
Dose-escalation design: Group 1 received 75 mg then 100 mg; Group 2 received 100 mg then 125 mg; placebo arm received lactose capsules identical in appearance. Primary outcome: change in LSAS social anxiety score; safety/tolerability assessed throughout and blind maintained through six-month follow-up.