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.
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.
Inactive lactose placebo capsules administered with manualised/nondirective therapy in two blinded 7-hour sessions.
Lactose capsules identical in appearance to MDMA; given during each experimental session.
Manualised, largely nondirective psychotherapy: three 1-h preparatory sessions and three 1-h integrative sessions per experimental session.
MDMA-assisted therapy with dose escalation: 75 mg in session 1, 100 mg in session 2 (unless contraindicated).
Session 1: 75 mg; Session 2 (~1 month later): 100 mg if tolerated.
Therapy as per manualised nondirective approach; preparatory and integrative sessions included.
MDMA-assisted therapy with dose escalation: 100 mg in session 1, 125 mg in session 2 (unless contraindicated).
Session 1: 100 mg; Session 2 (~1 month later): 125 mg if tolerated.
Therapy as per manualised nondirective approach; preparatory and integrative sessions included.