Recruiting
Phase 1

Psilocybin & Buprenorphine

Sponsor:

University of Wisconsin, Madison

Code:

NCT04161066

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Psilocybin with facilitated counseling

Study Details

Brief summary:

Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation.

Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy.

Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy.

Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.

Conditions

Opioid Use Disorder

Study ID

NCT04161066

Start date

Jan 13, 2021

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 21 to 65 years
  • Able to read, speak, and understand spoken and written English
  • Diagnosis of moderate or severe opioid use disorder (OUD)
  • Current opioid misuse, with misuse occurring on at least 10 of the last 30 days (at least 5 of last 30 days if already on buprenorphine/naloxene. See exclusion #1). Misuse will be defined as either:

1. Use of illicit opioids, such as heroin or street fentanyl; or use of a prescription opioid (such as oxycodone, morphine, or hydrocodone) through a route (e.g. nasal, injected) other than FDA approved , and/or
2. Use of a prescription opioid for a purpose (e.g. intoxication, anxiety relief) other than that for which it was prescribed.
  • Able to achieve stable daily dose of a buprenorphine-naloxone formulation that controls opioid withdrawal symptoms
  • Persons of childbearing potential must agree to practice an effective means of contraception throughout their participation in the study, beginning at screening and throughout follow-up
  • Ability and willingness to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and evaluations
  • Healthy kidney function
  • Able to provide contact information for a local support person. This person must be available during both 24-hour treatment and observation periods, and willing to provide the participant social/emotional support the day after each treatment and as needed during the dosing day and/or overnight observation period.

Exclusion Criteria:

  • Currently prescribed and has taken buprenorphine or buprenorphine formulation (e.g., Suboxone®) for over four months immediately prior to initial study contact
  • Currently receiving pharmacotherapy of any duration with methadone
  • Current participation in a drug treatment court program or other legal supervision. Individuals who are under legal supervision will be advised that participating in this study could potentially violate terms of probation, parole, or extended supervision. Contact information for the individual's community supervision officer must be collected to confirm whether study participation may impact the potential participant's status on probation or parole
  • Inadequately treated hypertension
  • Current acute coronary syndrome or angina
  • Evidence of ischemic disease, cardiac conduction defects, and/or ventricular arrhythmias on screening ECG
  • History of heart transplant
  • Current insulin dependence, due to Type I or Type II diabetes
  • Urine drug test containing non-prescribed drugs of abuse
  • Any finding(s), based on the screening process, that the PI feels makes the study unsuitable for the participant

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Open-label

Psilocybin with facilitated counseling: Psilocybin will be administered in the form of capsules, taken orally with water. Each participant will receive 2 doses, approximately 4 weeks apart.

Interventions

Psilocybin with facilitated counseling

open-label pilot study

Primary outcome measure

  • Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [ Time Frame: approximately Week 1 ]
  • Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose [ Time Frame: approximately Week 5 ]
  • Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument [ Time Frame: up to 5 weeks ]
  • Mean Change in Peripheral Capillary Oxygen [ Time Frame: up to 5 weeks ]
  • Mean Change in ECG [ Time Frame: up to 5 weeks ]

Central Contacts and Locations

Central contacts

PROTEA Research

608-444-2397protea.research@mailplus.wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Randall Brown, MD PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Psilocybin
  • Buprenorphine
  • Naloxone
  • Buprenorphine-Naloxone
  • Psilocybin-Assisted Therapy
  • Opioid
  • Substance Use Disorder
  • Psychedelic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-07.