ADEPT Psilocybin-Assisted Therapy With DBT for Borderline Personality Disorder

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07833761
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    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.
  • Psilocybin-Assisted Therapy With Dialectical Behavior Therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Sep 22, 2026
Start date
Dec 1, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DBT Plus Psilocybin-Assisted Therapy
    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.

Primary Outcome Measure

Incidence, Severity, and Frequency of Adverse Events [ Time Frame: Baseline through final study visit at week 18 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
M Health Fairview DBT ProgramMinneapolisMinnesota55455
Ziad Nahas, MD, MSCR
[email protected]
952-525-4505
M Physicians St. Louis Park ClinicSaint Louis ParkMinnesota55416
Ziad Nahas, MD, MSCR
[email protected]
952-525-4505

Find similar trials in Minneapolis, MN

By research site
M Health Fairview DBT Program· Minneapolis, MNM Physicians St. Louis Park Clinic· Saint Louis Park, MN

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