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ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Three preparation therapy visits will occur before the first dosing visit."
  • "The first dosing visit will be followed by three integration therapy visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe psilocybin-assisted therapy is and how well people can handle it while continuing dialectical behavior therapy (DBT). It is for adults ages 25 to 65 with borderline personality disorder who attend the M Health Fairview DBT program. Participants will have two supervised 25 mg psilocybin sessions, therapy before and after dosing, and a final follow-up visit.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of borderline personality disorder.
  • Have been in the M Health Fairview DBT program for at least one month, with regular group and one-on-one therapy attendance.
  • Be 25 to 65 years old.
  • Be able to speak and understand English.
  • Be able to complete all required study tests and forms without help or changes to protected test materials.
  • Be able to attend all study visits.
  • Agree to follow study steps and avoid changes to current treatments during the study.
  • If able to become pregnant, use an accepted birth control method, which may include not having sex.

Who can't join

  • Refuse to consent, or have limited or changing ability to give consent; be a child, a prisoner, unable to read, or unable to speak English.
  • Have a history of bipolar disorder, schizophrenia, psychosis (trouble knowing what is real), delusions, paranoia, or schizoaffective disorder; or have had a substance use disorder in the past 12 months.
  • Have a close blood relative, such as a parent, sibling, grandparent, aunt, or uncle, with schizophrenia or another psychotic disorder.
  • Have current thoughts of suicide with some intent or a plan, or have attempted suicide in the past six months.
  • Have autism or a current main diagnosis of post-traumatic stress disorder (PTSD).
  • Be pregnant or think you may be pregnant; have heart valve disease or high blood pressure in the lungs.
  • Have a mental or physical health condition or other circumstance that could make psilocybin unsafe, make it hard to build trust with the care team or meet study requirements, or affect the study's results.
  • Be an employee or student of the researcher, an active military member, or Department of Defense staff.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

MN