NCT06651177 · T. John Winhusen, PhD
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
(TAB)
What this study is about
The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
View original scientific description
The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
Interventions
DRUG
Tirzepatide
The tirzepatide pen is a pre-filled, disposable, injection device designed for subcutaneous administration. Each pen is pre-filled with a single dose of tirzepatide and is available in six doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg/0.5 mL. A UMC will administer the once-weekly SQ dose of tirzepatide. Consistent with tirzepatide's prescribing guidelines, participants will be initiated at a once-weekly SQ dose of 2.5 mg/week with a dose increase to 5mg/week at week 5. Consistent with tirzepatide's prescribing information, once the participant has received 5 mg/week for 4 weeks they are eligible for a dose increase if needed
OTHER
Placebo
Saline administered subcutaneously with a syringe will be used as the placebo for the trial. The placebo which will be administered by a study UMC. The process for deciding on "dose increases" will be the same for placebo and tirzepatide.
Primary outcome measures
6-month retention in BUP treatment
Time frame: 6 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must be ≥18 years of age; 2. Must have moderate to severe OUD; 3. Must, at the time of randomization, be newly initiated on BUP (i.e., within 7 to 28 days) during the current treatment episode, be taking ≥ the recommended target dose for transmucosal BUP (or equivalent for extended-release), and have documentation of receiving BUP, including dose and the start date of the current treatment episode, from their BUP provider; 4. Must be willing to be randomized to tirzepatide or placebo and to comply with study procedures, including weekly visits for 6 months; 5. Must be able to understand the study, and having understood, provide written informed consent in English; 6. Must not be breastfeeding; if of child bearing potential, must test negative on the study-administered pregnancy test(s), and if of childbearing potential and engaging /planning to engage in sexual intercourse must agree to effective contraception for the duration of the trial through 30 days after
Where
- Jacksonville, Florida
- Tampa, Florida
- Chicago, Illinois
- Cape Girardeau, Missouri
- Greenville, South Carolina
- Nashville, Tennessee
- Salt Lake City, Utah
- Huntington, West Virginia
- Morgantown, West Virginia
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2026 · Source of record for eligibility and locations