This is a randomised, open-label delayed treatment trial (n=90) aiming to evaluate the safety and efficacy of MDMA-assisted therapy for social anxiety disorder (SAD) in adults.
Led by Jason B Luoma at the Portland Psychotherapy Clinic, Research, and Training Center, this study targets participants aged 18 to 65 who reside in the Portland, OR, area and are fluent in English.
The trial involves two experimental sessions of MDMA-assisted therapy, with half of the participants receiving immediate treatment upon enrolment and the other half undergoing a 16-week wait period before treatment. Each experimental session includes manualised therapy alongside MDMA administration.
The primary outcome measure is the Liebowitz Social Anxiety Scale (LSAS) score assessed by a blinded Independent Rater. Additional assessments include measures of functional impairment, internalised shame, acceptance of self-conscious emotions, subjective belonging, self-concealment, and self-compassion. Recruitment commenced in April 2022 and is expected to conclude in August 2025.
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