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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 5, and week 9

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.

0 / 9Eligibility criteria met