drugset / Trial / NCT07833761

ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

NCT07833761 ↗

Phase 1 Not yet recruiting 18 enrolled University of Minnesota Filament Health Corp. · collab
NaSingle-groupOpen-labelTreatment

Summary

ADEPT is an open-label proof-of-concept study evaluating the safety and tolerability of psilocybin-assisted therapy in conjunction with Dialectical Behavior Therapy for participants with borderline personality disorder. Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive preparation therapy sessions, two supervised 25 mg psilocybin dosing sessions, integration therapy sessions, and a final follow-up visit. Participants will continue their usual DBT program during study participation. The study will primarily assess safety and tolerability, including adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging psychedelic experiences, psilocybin-related side effects, study retention, therapy session attendance, and assessment completion.

Timeline

Start
2026-12-01
Primary completion
2029-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 25 mg —