Phase 1, open-label, single-group study (n=150) assessing psychological effects and safety of a single 120 mg MDMA dose (optional 60 mg supplemental) paired with preparatory and integrative therapy sessions in healthy volunteers and therapists in training.
This Phase 1, multi-site study evaluates psychological effects and safety of manualised MDMA-assisted psychotherapy in healthy volunteers while supporting therapist training in MDMA-assisted approaches.
Participants receive a single 120 mg oral dose of MDMA (midomafetamine HCl) with an optional 60 mg supplemental dose 1.5–2 hours later, preceded by a non-drug preparatory session and followed by an integrative session; outcomes include mood, self-compassion, burnout, professional quality of life and related psychological measures.
One session of MDMA-assisted therapy with a dose of 120 mg midomafetamine HCl and an optional supplemental 60 mg 1.5–2 hours later.
Optional supplemental 60 mg 1.5–2 hours after initial dose.
Non-directive therapy conducted during the MDMA-assisted therapy session.