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

What Was Tested

The trial (phase 2) is built around Tirzepatide.

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.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This is a Phase 2, pragmatic, multi-site, double-blind, randomized, placebo-controlled, intent-to-treat trial.

The selection of placebo as the comparator is considered the gold standard for medication trials.

Eligible participants will be randomized in a 1:1 ratio to tirzepatide or placebo, balancing on site and buprenorphine (BUP) formulation (transmucosal vs extended-release).

Participants will be administered a subcutaneous (SQ) study medication injection weekly and attend weekly research visits through 26 weeks post-randomization with longer research visits at 1, 3, and 6 months post-randomization.

Who Took Part

Enrollment: 310 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Must be ≥18 years of age;. Must have moderate to severe OUD;. 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;. If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:.

The full record lists 11 inclusion and 13 exclusion criteria; among the exclusions: have a history of type 1 or type 2 diabetes mellitus (other than pregnancy-related diabetes);; have a bmi \<23.0 kg/m²;; have a known history of chronic or acute pancreatitis, gallbladder disease, gastroparesis, gastric emptying abnormality, gastroesophageal reflux disease, or other severe gastrointestinal disease;.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-01-29 with completion listed for 2027-09-30.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 6-month retention in BUP treatment (time frame: 6 months).

It also tracked 5 secondary outcomes, for example Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase, Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol, Sleep Quality - Fitbit Charge 6™ (FBC-6) and Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 310 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.