This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy (MDMA-AT) with three monthly experimental dosing sessions (80 mg first; 120 mg second and third; optional 50% supplemental dose).
Open-label, single-group proof-of-concept pilot (n=12) evaluating MDMA-assisted therapy for pathological narcissism. Treatment includes three preparation sessions, three monthly experimental MDMA sessions (80 mg first; 120 mg second and third; supplemental 50% dose available), and nine integration sessions.
Visit schedule: screening, three preparation visits, three experimental sessions each followed by three weekly integration sessions, and follow-up visits at 1 week, 1 month, 3 months and 6 months after final integration session to collect clinical outcome measures.
Midomafetamine (MDMA)-assisted therapy with preparation and integration sessions; single-group assignment.
Session 1: 80 mg; Sessions 2–3: 120 mg; supplemental dose of 50% of initial dose available after dosing (per protocol). Three preparation sessions and three weekly integration sessions after each experimental session.