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Opioid

Psilocybin + Counseling for Opioid Use Disorder

Phase 1
Recruiting
Led By Randall Brown, MD PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 21 to 65 years
Healthy kidney function
Must not have
Current acute coronary syndrome or angina
Current insulin dependence, due to Type I or Type II diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 5, and week 9
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at the effects of adding psilocybin to a buprenorphine/naloxone regimen in people with OUD. They will be looking at things like adverse events, quality of life, and pain.

Who is the study for?
Adults aged 21-65 with opioid use disorder (OUD) who are on a stable buprenorphine-naloxone treatment. Participants must have healthy kidneys, be able to understand English, and agree to use effective contraception. They should not be on methadone, under legal supervision that prohibits study participation, or have certain heart conditions or insulin-dependent diabetes.
What is being tested?
The trial is testing the safety and effects of adding two doses of psilocybin to ongoing buprenorphine-naloxone therapy for OUD. It aims to see if psilocybin can improve self-efficacy, quality of life, and pain while maintaining the effectiveness of buprenorphine-naloxone.
What are the potential side effects?
Possible side effects from psilocybin may include nausea, headache, dizziness, increased blood pressure or heart rate during dosing sessions. Psychological effects like anxiety or changes in perception could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.
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My kidneys are functioning well.
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I am diagnosed with opioid use disorder and am on prescribed buprenorphine.
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I have taken 20mg or less of buprenorphine daily for the last 10 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing heart-related chest pain.
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I am currently dependent on insulin for my diabetes.
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My high blood pressure is not well-controlled.
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I have had a heart transplant.
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I am currently taking methadone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 5, and week 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 5, and week 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in ECG
Mean Change in Peripheral Capillary Oxygen
Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument
+1 more
Secondary study objectives
Change in Opioid Craving Scale (OCS) from baseline through end of study
Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Heffter Research InstituteOTHER
14 Previous Clinical Trials
509 Total Patients Enrolled
Etheridge FoundationUNKNOWN
2 Previous Clinical Trials
35 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,237 Previous Clinical Trials
3,200,969 Total Patients Enrolled
Randall Brown, MD PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Buprenorphine (Opioid) Clinical Trial Eligibility Overview. Trial Name: NCT04161066 — Phase 1
Opioid Use Disorder Research Study Groups: Open-label
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04161066 — Phase 1
Buprenorphine (Opioid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04161066 — Phase 1
~1 spots leftby Jul 2025