ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder
Sponsored by University of Minnesota
About This Study
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.
Conditions Studied
Interventions
- •Psilocybin
- •Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
Eligibility
View full eligibility criteria
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