Social Anxiety MDMA-Assisted Therapy Investigation

Summary

This is a randomized, open-label delayed treatment study to assess the safety and effect of MDMA-assisted therapy in treating 20 participants diagnosed with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. This study will obtain an estimate of effect size for two experimental sessions of MDMA-assisted therapy for the treatment of social anxiety disorder on measures of safety, social anxiety, functional outcomes, psychiatric symptoms, and putative mechanisms of action. The primary outcome for this study will be the Liebowitz Social Anxiety Scale (LSAS) administered by a blinded Independent Rater (IR). Other assessments, including physiological, self-report, and behavioral tasks will be used to assess other exploratory variables. An additional aim of the trial will be the development of a treatment manual for MDMA-AT for SAD for future research.

Timeline

Start

2022-04-13

Primary completion

2025-02-06

Completion

2025-08-12

Publications

• Background Danforth AL, Grob CS, Struble C, Feduccia AA, Walker N, Jerome L, Yazar-Klosinski B, Emerson A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology (Berl). 2018 Nov;235(11):3137-3148. doi: 10.1007/s00213-018-5010-9. Epub 2018 Sep 8.
• Background Luoma J, Lear MK. MDMA-Assisted Therapy as a Means to Alter Affective, Cognitive, Behavioral, and Neurological Systems Underlying Social Dysfunction in Social Anxiety Disorder. Front Psychiatry. 2021 Sep 27;12:733893. doi: 10.3389/fpsyt.2021.733893. eCollection 2021.
• Background Luoma JB, Shahar B, Kati Lear M, Pilecki B, Wagner A. Potential processes of change in MDMA-Assisted therapy for social anxiety disorder: Enhanced memory reconsolidation, self-transcendence, and therapeutic relationships. Hum Psychopharmacol. 2022 May;37(3):e2824. doi: 10.1002/hup.2824. Epub 2021 Nov 5.
• Background Danforth AL, Struble CM, Yazar-Klosinski B, Grob CS. MDMA-assisted therapy: A new treatment model for social anxiety in autistic adults. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:237-49. doi: 10.1016/j.pnpbp.2015.03.011. Epub 2015 Mar 25.
• Lear MK, Smith SM, Pilecki B, Stauffer CS, Luoma JB. Social anxiety and MDMA-assisted therapy investigation: a novel clinical trial protocol. Front Psychiatry. 2023 Jul 14;14:1083354. doi: 10.3389/fpsyt.2023.1083354. eCollection 2023.

Drugs

Indications