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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 5, and week 9
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 between 21 and 65 years old.
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I can provide a contact for someone who will support me during and after my treatment.
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I am diagnosed with opioid use disorder and am on prescribed buprenorphine.
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My kidneys are functioning well.
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I am on a stable daily dose of medication that controls my opioid withdrawal symptoms.
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I am between 21 and 65 years old.
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I have taken 20mg or less of buprenorphine daily for the last 10 days.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in ECG
Mean Change in Peripheral Capillary Oxygen
Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument
+1 more
Secondary outcome measures
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)

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
13 Previous Clinical Trials
488 Total Patients Enrolled
Etheridge FoundationUNKNOWN
2 Previous Clinical Trials
66 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,177 Previous Clinical Trials
2,742,152 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of this trial?

"No longer taking on patients, this medical trial was first published in January 2021 and last modified in August 2022. However, if you are still searching for clinical trials related to drug abuse there are currently 533 studies recruiting participants and 33 clinical trials involving psilocybin with guided counseling also admitting people."

Answered by AI

What other exploratory investigations have been done utilizing Psilocybin in conjunction with counseling?

"At present, 33 trials investigating the effects of psilocybin with counceling are in progress. None have advanced to a phase 3 trial yet; however, 36 medical centres across multiple locations are testing this approach. Notably, there is an increase in Vancouver-based studies exploring the efficacy of this method."

Answered by AI

Are minors being accepted as participants in this experiment?

"The minimum age of admission to this clinical trial is 21 and the maximum allowed age is 65."

Answered by AI

Am I able to join this clinical experiment?

"This medical trial is seeking 10 participants who have a history of drug abuse and are between the ages 21 to 65."

Answered by AI

Are there any current opportunities to participate in the trial?

"Unfortunately, this research is no longer accepting patients. It was initially listed on January 13th 2021 and had its last update on August 19th 2022. However, there are currently 533 trials related to drug abuse that still have openings as well as 33 studies with Psilocybin supported therapy that need participants."

Answered by AI

Is the combination of Psilocybin and directed consultation sanctioned by the FDA?

"The safety rating of Psilocybin with guided counseling is a 1 given that this trial is in Phase 1, hence there are only limited evidence to demonstrate its efficacy and security."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
New Jersey
Wisconsin
Other
How old are they?
18 - 65
What site did they apply to?
University of Wisconsin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am interested in the long-term effects of buprenorphine and naloxone on the body.
PatientReceived no prior treatments
~0 spots leftby Jun 2024