A study testing whether a new weekly shot, tirzepatide, can help people use less opioids.
Recruiting now. Registry record last updated August 11, 2026.
- Who can join
- Adults 18+, have opioid use disorder, BMI 23+.
- What you take
- tirzepatide, given as part of the study. Check ClinicalTrials.gov for this trial's study groups, including any placebo or comparison medicine.
- How long it lasts
- The full study runs about 1.8 years; your own time in it is usually shorter.
- What you get
- Many clinical trials pay for the study medication and the study visits. Some also pay for travel. Ask the study team what this one covers before you sign the consent form.
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 80 days) during the current treatment episode, be taking ≥ 8 mg/day of generic buprenorphine-naloxone film/tablets (or the equivalent for other buprenorphine products), 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 trial 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: January 29, 2026. Expected completion: October 31, 2027. Last updated on ClinicalTrials.gov: August 11, 2026.
Official source
Every Monday we check this trial against ClinicalTrials.gov, the federal registry for clinical research. Last checked August 21, 2026. Confirm the current status there before you contact a site:
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