Actively Recruiting
Phase I Study of the Safety and Adjunctive Effects of Psilocybin in Adults With Opioid Use Disorder Maintained on a Buprenorphine/Naloxone Formulation
Led by University of Wisconsin, Madison · Updated on 2025-10-15
10
Participants Needed
1
Research Sites
4 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
This trial studies adults with opioid use disorder (OUD) who are receiving a stable daily dose of buprenorphine-naloxone. Researchers aim to understand the safety of adding two doses of psilocybin to this treatment and explore how psilocybin affects the effectiveness of buprenorphine-naloxone therapy. The study also seeks to describe changes in participants' self-efficacy, quality of life, and pain. Participants will receive two oral doses of psilocybin capsules about four weeks apart, along with facilitated counseling. Each dosing session occurs in a clinical research facility with two trained facilitators present. After eight hours of observation following dosing, participants stay overnight in a hospital unit and complete an integration session with a psychologist before discharge. Buprenorphine-naloxone therapy is initiated and maintained throughout the study under medical supervision. During the study, researchers will monitor safety through physiological measures like ECG, respiratory rate, blood pressure, and oxygen levels, as well as clinical scales for opioid withdrawal and craving. Participant opioid use is tracked via questionnaires. Follow-up assessments take place up to nine weeks post-treatment. The study lasts approximately this duration, with safety and symptom changes closely observed throughout.
CONDITIONS
Brief 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 English
- Diagnosis of moderate or severe opioid use disorder
- Current opioid misuse on at least 10 of the last 30 days, or at least 5 days if already on buprenorphine-naloxone
- Able to maintain a stable daily dose of buprenorphine-naloxone controlling withdrawal symptoms
- Persons of childbearing potential must use effective contraception during the study
- Willingness and ability to follow study requirements and attend all visits
- 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 before the study
- Receiving methadone treatment
- Participating in drug treatment court or under legal supervision that may be affected by study participation
- Untreated high blood pressure
- Current acute coronary syndrome or angina
- Evidence of ischemic disease, cardiac conduction defects, or ventricular arrhythmias
- History of heart transplant
- Insulin-dependent diabetes
- Positive urine test for non-prescribed drugs of abuse
- Any condition that makes the study unsuitable as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies based on stabilization needs prior to dosing
Participants begin and maintain a daily dose of buprenorphine-naloxone under medical supervision to stabilize withdrawal symptoms before psilocybin dosing.
Visits as needed for medication initiation and stabilization
Duration - Approximately 8 weeks (two dosing sessions about 4 weeks apart)
Participants receive two oral doses of psilocybin approximately 4 weeks apart, each followed by observation and integration counseling.
2 dosing visits with 8 hours observation each plus overnight hospital stay and integration session after each dose
Duration - Up to 4 weeks after the second dose
Participants complete follow-up assessments including safety and clinical measures after the last psilocybin dose, with continued monitoring of symptoms and opioid use.
Multiple follow-up visits up to Week 9
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
P
PROTEA Research
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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