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NOT YET RECRUITING

NCT07833761

PHASE1

ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

Sponsor: University of Minnesota

View on ClinicalTrials.gov

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.

Official title: ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-01

Completion Date

2030-12-31

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Borderline Personality Disorder Borderline Personality Pathology Depressive Symptoms Emotion Dysregulation Suicidal Ideation

Interventions

DRUG

Psilocybin

Participants will receive two 25 mg doses of psilocybin during supervised dosing visits. Each dosing visit will include study therapist support for a minimum of 6 hours, with preparation and integration therapy sessions before and after dosing.

BEHAVIORAL

Psilocybin-Assisted Therapy With Dialectical Behavior Therapy

Participants will continue in the M Health Fairview Dialectical Behavior Therapy program while receiving psilocybin-assisted therapy. The study therapy sequence includes three preparation visits before the first dosing session, three integration visits after the first dosing session, a second dosing session, and three additional integration visits.

Inclusion Criteria: * Confirmed DSM-5 diagnosis of borderline personality disorder using clinical records and measures used in the M Health Fairview DBT program * Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy * Age 25 to 65 years * Able to speak and understand English * Ability to complete all protocol-required assessment tools without assistance or alteration to copyrighted assessments * Ability to comply with all study visits * Stated willingness to comply with all study procedures and avoid changes to current treatments for the duration of the study * If of childbearing potential, use of an acceptable birth control method, including abstinence Exclusion Criteria: * Refusal to give informed consent * History of bipolar affective disorder type I or II, schizophrenia, psychosis, delusions, paranoia, schizoaffective disorder, or substance use disorder within the past 12 months * First- or second-degree relative with schizophrenia or any other psychotic disorder * Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS * History of suicide attempt in the last 6 months * Comorbid autism * Pregnant or may have reason to believe they are pregnant * Pre-existing valvular heart disease or pulmonary hypertension * Active primary PTSD diagnosis * Psychiatric or other condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin * Any medical or psychiatric disorder, disease, condition, injury, symptom, or circumstance that may reduce ability to fulfill study requirements, adversely impact data integrity or validity, or pose increased risk during study participation * Children * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Non-English speakers * Individuals unable to read * Employees of the researcher * Students of the researcher * Active members of the military or DoD personnel

Locations (2)

M Health Fairview DBT Program

Minneapolis, Minnesota, United States

M Physicians St. Louis Park Clinic

Saint Louis Park, Minnesota, United States