MDMA-Assisted Therapy for Social Anxiety Disorder: A Randomized, Open-label, Wait-list Controlled Trial
Jason B. Luoma, M. Kati Lear, Brian Pilecki, Jenna Lejeune, Kyong Yi, Christina Chwyl, Seth Mehr, Aryan Sarparast, Lilly Kennedy, Will Lucas, Angelica Spata, Christopher S. Stauffer
June 4, 2026 preprint DOI: 10.31234/osf.io/a9x6d_v1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Placebo-controlled Open-label Preregistered |
|---|---|
| Sample size | 20 |
| Population | Adults diagnosed with social anxiety disorder |
| Intervention | MDMA-Assisted Therapy |
| Duration | 16-week primary outcome |
| Topics | Anxiety MDMA |
| Keywords | Social anxiety Randomized controlled trial Adverse effect Clinical trial Rating scale Clinical psychology Social functioning |
| Registration | NCT05138068 |
| Key findings | MDMA-Assisted Therapy led to a significantly greater reduction in social anxiety symptoms than a waitlist condition, with a mean difference of −43.3 on the Liebowitz Social Anxiety Scale. |
Abstract
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.
Aims: 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.
Method: 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.
Results: 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.
Conclusions: 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
In the evidence
This study is part of the evidence base for a synthesis in the library. Here is how each one recorded it.
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MDMA-assisted therapy led to a significantly greater reduction in social anxiety symptoms than a waitlist condition, with a mean difference of -43.3 on the Liebowitz Social Anxiety Scale.
Synthesized
Comparable studies
Other randomized controlled trials on MDMA for anxiety, most cited first.