Social Anxiety MDMA-Assisted Therapy Investigation
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Jason B Luoma
Collaborators:
Multidisciplinary Association for Psychedelic Studies Oregon Research Institute Center for Evaluation Services Portland Psychotherapy Clinic, Research, & Training Center