Psilocybin-Assisted Therapy for Borderline Personality Disorder

(ADEPT Trial)

Not yet recruiting at 1 trial location
RJ
ZN
Overseen ByZiad Nahas, MD, MSCR
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ZN

Ziad Nahas, MD, MSCR

Principal Investigator

University of Minnesota

DH

Devin H Hanson, PhD, LP

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with borderline personality disorder who are already enrolled in a Dialectical Behavior Therapy (DBT) program. Participants should be able to attend therapy sessions and follow study procedures.

Inclusion Criteria

Able to speak and understand English
Enrolled in the M Health Fairview DBT program for at least one month, with consistent attendance in group and individual therapy
Ability to comply with all study visits
See 5 more

Exclusion Criteria

Individuals unable to read
Refusal to give informed consent
Students of the researcher
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin
  • Psilocybin-Assisted Therapy With Dialectical Behavior Therapy

Trial Overview

The study tests the safety of psilocybin-assisted therapy combined with ongoing DBT. Participants receive two supervised doses of psilocybin, along with preparation and integration therapy sessions, while continuing their regular DBT treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DBT Plus Psilocybin-Assisted TherapyExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Filament Health Corp.

Industry Sponsor

Trials
4
Recruited
220+