This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy (MDMA-AT) (80 mg for the first session, 120 mg for the second and third, with an optional supplemental dose of 50% of the initial dose) for participants diagnosed with pathological narcissism.
Conducted by the University of Washington and led by Dr Anthony Back, the study will involve a screening period, three preparation sessions, three monthly experimental therapy sessions with MDMA, and nine integration sessions. Follow-ups will be conducted at one week, one month, three months, and six months post-treatment.
Participants will be required to have an identified family member and psychotherapist as informants. The trial aims to evaluate the impact of MDMA-AT on pathological narcissism symptoms, with study completion expected by early 2027.
Trial Details
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.Trial Number NCT06565494
Sponsors & Collaborators
University of Washington in SeattleResearch into the therapeutic potential of psychedelics is underway at Washington State University.