Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine

Recruiting now · Phase 1

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT04161066

Run by

University of Wisconsin, Madison

People needed

10

Starts

2021-01-13

Expected to finish

2026-12-01

Last updated by the study team

2026-07-07

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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)
• 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:
• 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

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.