A study testing whether a new weekly shot from T. John Winhusen, PhD, tirzepatide, can help people use less opioids.
What this means for you
- Who can join
- Adults 18+, have opioid use disorder, BMI 23+.
- What you take
- tirzepatide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 1.8 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Opioid Use Disorder. Also studied in: Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe.
Full scientific study title: Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder.
Who can join
Adults 18+, have opioid use disorder, BMI 23+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- Must be >=18 years of age;
- Must have moderate to severe OUD;
- Must, at the time of randomization, be newly initiated on BUP (i.e., within 7 to 60 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, and, for participants prescribed transmucosal BUP, have at least one UDS positive for buprenorphine/norbuprenorphine;
- Must be willing to be randomized to tirzepatide or placebo and to comply with study procedures, including weekly visits for 6 months;
- Must be able to understand the study, and having understood, provide written informed consent in English;
Key exclusion criteria
- have a history of type 1 or type 2 diabetes mellitus (other than pregnancy-related diabetes);
- have a BMI <23.0 kg/m²;
- have any of the following cardiovascular conditions within 90 days prior to signing consent: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF);
- have a known history of chronic or acute pancreatitis, gallbladder disease, gastroparesis, gastric emptying abnormality, gastroesophageal reflux disease, or other severe gastrointestinal disease;
- have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
Where this study is enrolling
This trial has 9 sites across 7 states. Contact a site coordinator directly to start screening.
Florida2 sites
- Gateway Community ServicesJacksonville, Florida
- IBIS Behavioral HealthTampa, Florida
Illinois1 site
- Ruth M. Rothstein CORE CenterChicago, Illinois
Missouri1 site
- The Gibson Center for Behavioral ChangeCape Girardeau, Missouri
South Carolina1 site
- Prisma HealthGreenville, South Carolina
Tennessee1 site
- Vanderbilt University Medical CenterNashville, Tennessee
Utah1 site
- University of UtahSalt Lake City, Utah
West Virginia2 sites
- Marshall HealthHuntington, West Virginia
- Healthy Minds/Chestnut RidgeMorgantown, West Virginia
Timeline
Started enrolling: 2026-01-29. Expected completion: 2027-10-31. Last updated on ClinicalTrials.gov: 2026-05-22.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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