drugset / Trial / NCT06565494
MDMA-Assisted Therapy for Pathological Narcissism
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midomafetamine | Unknown | 120 mg | — |