Social Anxiety MDMA-Assisted Therapy Investigation (SAMATI): A Randomized, Delayed Treatment Control Phase 2 Study of the Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Social Anxiety Disorder

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.

Study Timeline

Study Research Site: 
Portland Psychotherapy Clinic, Research, & Training Center

Portland, Oregon

Primary Contact:
Jason Luoma, Ph.D.

Study Websites: