A study testing whether a new weekly shot from T. John Winhusen, PhD, tirzepatide, can help people use less opioids.

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

Full study title: Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder.

Primary condition: Opioid Use Disorder. Also studied in: Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe.

Who can join, in detail

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 US sites across 7 states. Contact the site coordinator directly to start the screening process.

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:

View on ClinicalTrials.gov →

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