RecruitingPhase 2NCT06651177

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

NIDA CTN-0152: Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder: A Pragmatic, Multi-site, Double-blind, Randomized, Placebo-controlled Trial (TAB)

Sponsor

T. John Winhusen, PhD

Enrollment

310 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder Opioid Use Disorder, Moderate Opioid Use Disorder, Severe

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tirzepatide — a medication originally approved for type 2 diabetes and weight loss — as an addition to buprenorphine (a standard medication for opioid use disorder) to see if it improves treatment outcomes, including reducing opioid use and cravings. **You may be eligible if...** - You are 18 or older - You have moderate to severe opioid use disorder (OUD) - You have recently started buprenorphine (within the past 7–28 days) and are taking at least the recommended dose - You are willing to attend weekly visits for 6 months - You can read and understand English **You may NOT be eligible if...** - You are not currently on buprenorphine or started it more than 28 days ago - You have medical conditions that make tirzepatide unsafe (e.g., personal or family history of a specific type of thyroid cancer, pancreatitis) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTirzepatide

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

OTHERPlacebo

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.