drugset / Trial / NCT06565494

MDMA-Assisted Therapy for Pathological Narcissism

NCT06565494

Phase 0 Active not recruiting 12 enrolled University of Washington
NaSingle-groupOpen-labelTreatment

Summary

This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine (MDMA) - assisted therapy (AT) for participants diagnosed with pathological narcissism. As all participants will be allocated to a single group assignment, there will be no blinding, randomization, or comparator treatment. Participants will have a screening visit, a preparation period of 3 visits, a treatment period receiving MDMA-AT at 3 monthly visits, a 6 month follow up period coming in at one week, one month, three months and six months after last treatment visit.

Timeline

Start
2024-08-27
Primary completion
2026-08-15
Completion
2027-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Midomafetamine Unknown 120 mg