Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol
M. Kati Lear, Sarah M. Smith, Brian Pilecki, Chris S. Stauffer, Jason B. Luoma
Frontiers in Psychiatry July 15, 2023 DOI: 10.3389/fpsyt.2023.1083354 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized open-label delayed treatment pilot study Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | Adults with moderate-to-severe generalized social anxiety disorder |
| Intervention | MDMA-assisted therapy |
| Duration | 16-week intervention period for immediate treatment condition; 6-month follow-up |
| Topics | MDMA Anxiety |
| Keywords | Social anxiety disorder Psychedelic research Clinical trial protocol Psychedelic assisted therapy MDMA Sessions Transformative treatment Debilitating condition Pioneering effort |
| Citations | 14 |
| Registration | NCT05138068 |
| Key points | The protocol aims to assess preliminary treatment outcomes, feasibility, safety, and psychological and physiological processes of change in MDMA-assisted therapy for social anxiety disorder. |
Abstract
BackgroundSocial anxiety disorder (SAD) is a serious and prevalent psychiatric condition that heavily impacts social functioning and quality of life. Though efficacious treatments exist for SAD, remission rates remain elevated and a significant portion of those affected do not access effective treatment, suggesting the need for additional evidence-based treatment options. This paper presents a protocol for an open-label pilot study of MDMA-assisted therapy (MDMA-AT) for social anxiety disorder. The study aims to assess preliminary treatment outcomes, feasibility and safety, and psychological and physiological processes of change in the treatment of SAD with MDMA-AT. A secondary aim includes the development of a treatment manual for MDMA-AT for SAD.MethodThe outlined protocol is a randomized, open-label delayed treatment study. We will recruit 20 participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. Participants will be randomly assigned to an immediate treatment (n = 10) or delayed treatment condition (n = 10). Those in the immediate treatment condition will proceed immediately to active MDMA-AT consisting of three preparation sessions, two medicine sessions in which they receive oral doses of MDMA, and six integration sessions over approximately a 16-week period. The delayed treatment condition will receive the same intervention after a 16-week delay. Our primary outcome is SAD symptom reduction as measured by the Liebowitz Social Anxiety Scale administered by blinded raters at post-treatment and 6 month follow up. Secondary outcomes include changes in functional impairment, feasibility and safety measures, and novel therapeutic processes of change including shame and shame-related coping, belongingness, self-concealment, and self-compassion at post-treatment. Exploratory outcomes are also discussed.DiscussionThe results of this pilot trial advance the field’s understanding of the acceptability and potential effectiveness of MDMA-AT for social anxiety disorder and provide an overview of relevant therapeutic mechanisms unique to SAD. We hope findings from this protocol will inform the design of subsequent larger-scale randomized controlled trials (RCT) examining the efficacy of MDMA-AT for SAD.Clinical trial registrationhttps://clinicaltrials.gov/, NCT05138068.
Comparable studies
Other randomized controlled trials on MDMA for anxiety, most cited first.