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Can psilocybin boost the power of talk therapy for borderline personality disorder?

NCT ID NCT07833761

Symptom relief Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers at the University of Minnesota are testing whether psilocybin-assisted therapy can be safely added to dialectical behavior therapy (DBT) for adults with borderline personality disorder. Participants stay in their usual DBT program while receiving preparation sessions, two supervised 25 mg doses of psilocybin, and integration therapy. The trial primarily tracks safety and tolerability, including side effects, suicidal ideation, and how many participants complete the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin, a psychedelic drug, given alongside dialectical behavior therapy
What this could lead to
If it proves safe and tolerable, this could point toward a new way to combine psychedelic-assisted therapy with an established talk therapy for borderline personality disorder.
What could go wrong
This is a very small, early-stage trial with no control group, so it cannot show whether the combination works better than DBT alone. Psilocybin can cause intense or distressing experiences, and people with borderline personality disorder may be especially vulnerable to emotional ups and downs during dosing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

borderline personality disorder Depression Suicidal Ideation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Borderline personality disorder Borderline personality pathology Depressive symptoms Emotion dysregulation Suicidal ideation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • M Health Fairview DBT Program

    Minneapolis, Minnesota, 55455, United States

  • M Physicians St. Louis Park Clinic

    Saint Louis Park, Minnesota, 55416, United States

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