ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

ADEPT is an open-label proof-of-concept study designed to assess the safety and tolerability of combining psilocybin-assisted therapy with Dialectical Behavior Therapy in participants with borderline personality disorder.

The study will enroll up to 18 participants who have a confirmed DSM-5 diagnosis of borderline personality disorder and are enrolled in the M Health Fairview Dialectical Behavior Therapy program. Participants must have been enrolled in DBT for at least one month and must have consistent attendance in both group and individual therapy.

The study intervention includes two 25 mg doses of psilocybin administered during supervised dosing visits. Three preparation therapy visits will occur before the first dosing visit. The first dosing visit will be followed by three integration therapy visits. A second psilocybin dosing visit will occur approximately 21 days later, followed by three additional integration therapy visits. Participants will complete a final follow-up visit at week 18, approximately 12 weeks after the second dosing visit.

Participants will continue their usual DBT program while enrolled in the study. The M Health Fairview DBT program includes weekly individual therapy, group therapy skills development, and access to phone coaching.

The primary focus of the study is safety and tolerability. Participants will be monitored during and after dosing, and adverse events, treatment-emergent adverse events, serious adverse events, suicidal ideation, challenging experiences, and psychedelic-related side effects will be assessed. Secondary outcomes will evaluate changes in borderline personality disorder symptoms, emotion regulation, depressive symptoms, quality of life, treatment credibility and expectancy, mystical experience, and continued participation in DBT after psilocybin-assisted therapy.

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