MDMA-Assisted Therapy for Social Anxiety Disorder: A Randomized, Open-label, Wait-list Controlled Trial
Abstract
<p>Background: ±3,4-methylenedioxymethamphetamine (MDMA) has positive effects on socio-emotional processing and MDMA-Assisted Therapy (MDMA-AT) showed promise for treating SAD in a previous placebo-controlled trial. <h4>Aims:</h4> Develop a preliminary estimate of clinical response and safety for MDMA-AT versus waitlist in adults with SAD. Secondary aims included refinement of a standardized psychotherapy manual and assessment of candidate therapeutic processes. <h4>Method:</h4> This randomized, open-label, wait-list controlled clinical trial recruited and enrolled 20 participants diagnosed with SAD from April, 2022 to March, 2024. They were randomly assigned to either immediate treatment with MDMA-AT or a 16-week waitlist condition followed by MDMA-AT equivalent to the immediate treatment arm. MDMA-AT consisted of three 90-minute preparation sessions, two MDMA sessions, and six 90-minute integration sessions. The preregistered primary outcome was the Leibowitz Social Anxiety Scale; secondary outcomes were functioning, shame, acceptance, belongingness, self-concealment, and self-compassion. <h4>Results:</h4> Across 20 participants (45% women, 40% men, 15% transgender; 85% White; mean age 38) we observed a mean difference on the Leibowitz Social Anxiety Scale at 16-week primary outcome of −43.3 (SD = 14.7; 95% CI, −29.5 to −57.1; p < .0001; Hedge’s g = 2.8) indicating greater improvement in the MDMA-AT condition. No serious adverse events occurred; adverse events were mild to moderate and transient. <h4>Conclusions:</h4> MDMA-AT resulted in a significant reduction in social anxiety symptoms and improvement in functioning compared to waitlist. There were no serious adverse events. Findings provide preliminary data for efficacy, safety, and feasibility of MDMA-AT for SAD, supporting the need for further investigation. Trial Registration: https://clinicaltrials.gov/study/NCT05138068 Key words: MDMA, MDMA-AT, social anxiety disorder, clinical trial, RCT, psychedelics</p>
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