MDMA-Assisted Therapy for Pathological Narcissism

This open-label, proof-of-concept pilot study (n=12) will assess the efficacy and safety of midomafetamine (MDMA)-assisted therapy for participants diagnosed with pathological narcissism.

The study, conducted from August 2024 to January 2027, aims to explore MDMA-assisted therapy as a potential treatment for pathological narcissism. Participants will undergo a screening period, followed by a preparation period with three sessions, and a treatment period consisting of three monthly experimental sessions with MDMA.

The initial dose will be 80 mg for the first session, increasing to 120 mg for the second and third sessions, with a supplemental dose of 50% available for each. Each experimental session will be followed by three weekly integration sessions. The study includes a six-month follow-up period with assessments at one week, one month, three months, and six months post-treatment.

Unique to this study, each participant will have two informants: a family member and a psychotherapist. As an early Phase I trial without blinding, randomisation, or a control group, this research seeks to establish initial evidence for the potential of MDMA-assisted therapy in treating pathological narcissism.

Topic Personality
Compound MDMA
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 27 August 2024
End date 31 January 2027
Chance of happening 100%
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 12
Sex All
Age 18- 64
Therapy Yes

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.

NCT Number NCT06565494

Sponsors & Collaborators

Washington University School of Medicine
Located in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.

Data attribution

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