Actively Recruiting
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
Led by University of Wisconsin, Madison · Updated on 2025-10-15
10
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
H
Heffter Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Adjunctive Effects of Psilocybin and a Formulation of Buprenorphine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 on at least 10 of the last 30 days or at least 5 of last 30 days if already on buprenorphine/naloxone
- Able to achieve stable daily dose of buprenorphine-naloxone controlling withdrawal symptoms
- Persons of childbearing potential must agree to effective contraception throughout the study
- Ability and willingness to attend all study visits, preparatory and follow-up sessions, and evaluations
- Healthy kidney function
- Able to provide contact information for a local support person available during treatment and observation periods
You will not qualify if you...
- Taking buprenorphine or buprenorphine formulation for over four months immediately prior to study contact
- Receiving methadone pharmacotherapy of any duration
- Participating in a drug treatment court program or other legal supervision
- Inadequately treated hypertension
- Current acute coronary syndrome or angina
- Evidence of ischemic disease, cardiac conduction defects, or ventricular arrhythmias on ECG
- History of heart transplant
- Current insulin-dependent diabetes
- Urine drug test positive for non-prescribed drugs of abuse
- Any other condition making the study unsuitable as determined by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
P
PROTEA Research
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here