NCT06565494

MDMA-Assisted Therapy for Pathological Narcissism

A Pilot Study of Midomafetamine (MDMA-Assisted) Therapy for the Treatment of Pathological Narcissism

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This open-label, proof-of-concept pilot study will assess the efficacy and safety of midomafetamine- assisted therapy (MDMA-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. Up to 12 participants will be enrolled. Each participant will have 2 informants, one family member and one psychotherapist. The visit schedule for each participant will be comprised of the following: * Screening Period: phone screen, visit screen, informed consent, eligibility assessment, and enrollment invitation to eligible participants; * Preparation Period: medication tapering, three Preparation Sessions, Baseline assessments, Enrollment Confirmation; * Treatment Period: three monthly Experimental Sessions and nine associated Integration Sessions over \~12 weeks; * Follow-up Period and Study Termination: four Follow-up Visits at one week, one month, three months and six months after the final Integration Session to collect clinical outcome measures; Study Termination will happen at the last Follow-up Visit. The treatment (MDMA-AT) consists 3 Preparation sessions followed by 3 Experimental sessions at 4-week intervals; after each Experimental session, 3 weekly Integration sessions will be conducted. For the first Experimental Session, the dose of MDMA is 80 mg; for the second and third Experimental Sessions, the dose of MDMA is 120 mg. For all three Experimental sessions, a supplemental dose of 50% of the initial dose will be available. The Preparation, Experimental, and Integration Sessions will involve psychotherapy developed specifically for this trial and population.

Conditions

• Narcissism

Interventions

Type	Name	Description
DRUG	midomafetamine (MDMA)-Assisted Therapy	This treatment consists 3 Preparation sessions followed by 3 Experimental sessions at 4-week intervals; after each Experimental session, 3 weekly Integration sessions will be conducted. For the first Experimental Session, the dose of MDMA is 80 mg; for the second and third Experimental Sessions, the dose of MDMA is 120 mg. For all three Experimental sessions, a supplemental dose of 50% of the initial dose will be available. The Preparation, Experimental, and Integration Sessions will involve psychotherapy developed specifically for this trial and population.

Timeline

• Start date: 2024-08-27
• Primary completion: 2026-08-15
• Completion: 2027-01-31
• First posted: 2024-08-22
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study