Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

NCT04161066 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: 2019-0187A532007SMPH/FAMILY MEDICINEProtocol Version 02/17/2025
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose

  In participants with OUD, the safety of this intervention will be assessed by characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine regimen.

  approximately Week 1

• Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose

  In participants with OUD, the safety of this intervention will be assessed by characterizing adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone regimen.

  approximately Week 5

• Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument

  It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause signs and symptoms of opioid withdrawal. This will be measured by the Clinical Opiate Withdrawal Scale (COWS) instrument, an 11-item scale administered by the clinician where total score of: 5- 12 = mild withdrawal; 13-24 = moderate withdrawal; 25-36 = moderately severe withdrawal; and more than 36 = severe withdrawal. Administered before the dose and again 8 hours after the dose.

  up to 5 weeks

• Mean Change in Peripheral Capillary Oxygen

  It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause opioid intoxication. Opioid intoxication will be determined by drops peripheral capillary oxygen saturation (SpO2) before and after dosing.

  up to 5 weeks

• Mean Change in ECG

  It is hypothesized that co-administration of oral psilocybin with a buprenorphine-naloxone formulation will not cause a clinically significant increase in the QTc interval. The QTc interval will be measured by electrocardiogram (ECG) before and after dosing. If a QTc(F), calculated by the CardioCard system exceeds 470msec, a study physician will be contacted immediately for further monitoring and treatment recommendations.

  up to 5 weeks

Secondary Outcomes (2)

• Change in Opioid Craving Scale (OCS) from baseline through end of study

  Baseline, Week 1, Week 5, and Week 9

• Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB)

  up to 9 weeks

Study Arms (1)

Open-label

EXPERIMENTAL

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.

Drug: Psilocybin with facilitated counseling

Interventions

Psilocybin with facilitated counseling DRUG

open-label pilot study

Open-label

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21 to 65 years
• Able to read, speak, and understand spoken and written English
• Diagnosis of moderate or severe opioid use disorder (OUD)
• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Heffter Research Institute: collaborator
• Etheridge Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

Related Links

• Click this link to contact us to see if you qualify

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Randall Brown, MD PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PROTEA Research

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label pilot study

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: November 13, 2019
• Study Start: January 13, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)