Early access
Sign in
Not yet taking people in United StatesPhase 1

ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

Key facts

Who runs it
University of Minnesota
Where
Minneapolis and Saint Louis Park, United StatesSee the 2 sites
Trial code
Status
Not yet recruiting
Phase
Phase 1
People taking part
18 people, planned
Starts
1 Dec 2026
Expected to end
31 Dec 2030
Type of study
Interventional
Treatments tested
  • Psilocybin
  • Psilocybin-Assisted Therapy With Dialectical Behavior Therapy
Record updated
22 September 2026

Who can take part

Age
25 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • History of suicide attempt in the last 6 months
  • Pre-existing valvular heart disease or pulmonary hypertension
  • 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
  • Refusal to give informed consent
  • Active suicidal ideation with at least some intent and/or plan, defined as a current score of 4 or 5 on the C-SSRS
  • Comorbid autism
  • Pregnant or may have reason to believe they are pregnant
  • Active primary PTSD diagnosis
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 25 and 65 years old?

Where in United States

  • M Health Fairview DBT ProgramMinneapolis, United StatesContact: Ziad Nahas, MD, MSCRNot yet recruiting
  • M Physicians St. Louis Park ClinicSaint Louis Park, United StatesContact: Ziad Nahas, MD, MSCRNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • DBT Plus Psilocybin-Assisted TherapyTreatment being tested

    Participants enrolled in the M Health Fairview Dialectical Behavior Therapy program will receive psilocybin-assisted therapy in addition to ongoing DBT. The study includes three preparation visits, two psilocybin dosing visits, integration visits after each dosing visit, and a final follow-up visit at week 18.

    Treatment: Psilocybin and Psilocybin-Assisted Therapy With Dialectical Behavior Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
ADEPT: Augmenting DBT Effectiveness With Psilocybin-Assisted Therapy
Fit questions
Built from NCT07833761, who can take part
Record updated
22 September 2026