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Tirzepatide for Opioid Use Disorder

This study is looking at whether tirzepatide, a medication given by injection, can help people with moderate to severe opioid use disorder (OUD) stay in treatment with buprenorphine (BUP). You might be able to join if you are 18 or older and have recently started buprenorphine treatment (within 7 to 60 days). The main goal is to see how many people stay on buprenorphine treatment for 6 months. This study compares tirzepatide to a placebo (a saline injection with no active medicine) to understand its effects on treatment retention, substance use, and sleep.

Study design
This is a Phase 2, multi-site, double-blind, randomized study with 310 planned participants. You would be randomly assigned to receive either tirzepatide or a placebo.
What's involved
You would receive a study medication injection weekly and attend weekly research visits for 26 weeks. There will also be longer research visits at 1, 3, and 6 months, and a final safety visit at week 30.
Compensation
Not stated in the trial record.
Follow-up
You will have a follow-up visit for safety measures at week 30, after the 6-month treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06651177

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

Recruiting
PHASE2Ages 18+InterventionalTreatment
T. John Winhusen, PhD
~310 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:TirzepatidePlacebo

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6-month retention in BUP treatment
Measured over 6 months

Conditions

Opioid Use Disorder
Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe

Explore related trials

Opioid Use Disorder

Where it's being run

9 sites across 7 states
Florida2
West Virginia2
Illinois1
Missouri1
South Carolina1
Tennessee1
Utah1

Study leadership

  • T. John Winhusen, PhD. · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

Frankie B Kropp, MS, LICDC
[email protected]
513-585-8290
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:

What this trial measures

  • 6-month retention in BUP treatment6 months

    MOUD is defined as buprenorphine (BUP). The receipt of BUP will be assessed thorough self-report collected through a Timeline Follow-Back (TLFB) procedure and will be partially verified through urine drug screens.