Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol
Frontiers in Psychiatry July 15, 2023 M. Kati Lear, Sarah M. Smith, Brian Pilecki et al. 14 citations
An open-label pilot study will test MDMA-assisted therapy for social anxiety disorder. Twenty participants with moderate-to-severe generalized social anxiety will be randomly assigned to immediate or delayed treatment. The immediate group receives three preparation sessions, two MDMA medicine sessions, and six integration sessions over about 16 weeks. The primary outcome is symptom reduction measured by the Liebowitz Social Anxiety Scale at post-treatment and 6-month follow-up. Secondary outcomes include changes in functional impairment, safety, and processes like shame, belongingness, self-concealment, and self-compassion. Results will inform the design of larger randomized controlled trials.