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Social Anxiety MDMA-Assisted Therapy Investigation (SAMATI)

RecruitingRegisteredCTG

Randomized, open-label delayed-treatment Phase 2 study (n=20) assessing two MDMA-assisted therapy sessions (80 mg initial ±40 mg supplemental; second session may be 120 mg initial ±40 mg) plus preparatory/integrative psychotherapy for adults with generalized social anxiety disorder.

Details

Randomized, open-label delayed treatment (parallel) design with half the sample treated immediately and half after a 16-week wait; primary outcome is LSAS rated by a blinded independent rater.

Intervention comprises 3×90-minute preparatory sessions, 2×8-hour experimental MDMA sessions (supplemental 40 mg 1.5–2 h after initial dose), and 3×90-minute integration sessions; assessments include safety, social anxiety, functional outcomes and mechanistic measures.

Topics:Anxiety Disorders

Registry

Registry linkNCT05138068