Tirzepatide for Opioid Use Disorder

(TAB Trial)

Not yet recruiting at 9 trial locations

Overseen By Benjamin T Kropp, MSLS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: T. John Winhusen, PhD

Must be taking: BUP

Must not be taking: GLP-1 analogs, Insulin, Steroids

Disqualifiers: Diabetes, Cardiovascular conditions, Gastrointestinal disease, others

Stay on Your Current Meds You can continue your current medications while participating

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether tirzepatide, a medication, can aid individuals with opioid use disorder (OUD) when combined with their current treatment, buprenorphine (BUP). The goal is to determine if tirzepatide helps participants stay in treatment longer, reduce substance use, and improve sleep. Participants will receive either tirzepatide or a placebo (a non-active substance) to compare outcomes. The trial seeks individuals with moderate to severe OUD who have recently started buprenorphine treatment. As a Phase 2 trial, this research measures how well tirzepatide works in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use certain medications like those for lowering blood sugar or systemic steroids during the trial.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Earlier studies have found tirzepatide to be generally safe and well-tolerated for weight loss, with most participants experiencing few serious side effects. When used for other conditions, tirzepatide has also reduced cravings, showing promise for treating addiction.

Although researchers are still studying tirzepatide for various uses, its good safety record for weight loss suggests it might also be safe for treating opioid use disorder. However, as this is a Phase 2 trial, researchers are still assessing its safety for this specific purpose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for opioid use disorder?

Most treatments for opioid use disorder involve medications like methadone, buprenorphine, or naltrexone, which target opioid receptors to reduce cravings and withdrawal symptoms. However, tirzepatide is unique because it taps into a different mechanism. Originally developed for diabetes management, tirzepatide is a GLP-1 receptor agonist that influences insulin secretion and appetite regulation, which researchers believe might also help modulate the brain's reward system linked to addiction. This new approach could offer a fresh avenue for treating opioid use disorder, potentially addressing both metabolic and neurological aspects of the condition. Researchers are excited about the potential of tirzepatide to offer a novel pathway to recovery, with a different mechanism than traditional opioid-focused treatments.

What evidence suggests that tirzepatide might be an effective treatment for opioid use disorder?

Research has shown that tirzepatide, a medication for diabetes, might also aid individuals with opioid use disorder (OUD). One study involving over a million patients found that those who began taking drugs like tirzepatide had a 40% lower risk of issues related to opioid or alcohol use. This suggests tirzepatide could help reduce substance use. In this trial, participants will receive either tirzepatide or a placebo to evaluate its effectiveness specifically for OUD. The goal is for tirzepatide to help individuals with OUD remain in treatment longer and reduce substance use. While these findings are encouraging, further research is needed to confirm its efficacy. ^{1 6 7 8 9}

Who Is on the Research Team?

T. John Winhusen, PhD.

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

This trial is for individuals with moderate to severe opioid use disorder who have recently started treatment with Buprenorphine. Participants must be willing to follow the study procedures, including weekly visits for six months, and not be breastfeeding. Women of childbearing potential must agree to effective contraception during and after the trial.

Inclusion Criteria

I have moderate to severe opioid use disorder.

I am willing to possibly receive a placebo and follow the study's weekly visit schedule for 6 months.

I understand the study details and can consent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or placebo with weekly subcutaneous injections and attend weekly research visits

26 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study aims to test Tirzepatide as an additional treatment alongside Buprenorphine compared to a placebo. The focus is on how well patients stick with their treatment, changes in substance use, and sleep outcomes over a six-month period.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

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. An unblinded study MC (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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

T. John Winhusen, PhD

Lead Sponsor

Trials

5

Recruited

750+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. nida.nih.gov nida.nih.gov/about-nida/organization/cctn/ctn/research-studies/effects-semaglutide-tirzepatide-incidence-outcomes-stimulant-use-disorders-opioid-use-disorder-in

Effects of Semaglutide and Tirzepatide on Incidence and ... This study aims to evaluate the effectiveness of semaglutide and tirzepatide, which are new and particularly potent GLP-1RAs, in reducing the incidence of and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0033062024001798

Tirzepatide and semaglutide for treating obesity-related ... Similarly, an observational study of 1.3 million patients with opioid use disorder or AUD reported that those who were started on a GLP-1RA had a 40 % lower ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06994338

NCT06994338 | Tirzepatide for Alcohol Use Disorder The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16679

The association between glucose‐dependent ... Opioid use and OUD have been associated with many adverse health outcomes and result severe economic burden [6, 7].

5. withpower.com withpower.com/trial/phase-2-substance-related-disorders-8-2025-201ad

Tirzepatide for Opioid Use Disorder · Info for Participants 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103286/

Anti-Consumption Agents: Tirzepatide and Semaglutide for ... Tirzepatide and semaglutide, unlike prior weight-loss drugs, are effective and relatively safe/well-tolerated medications that improve nearly all the negative ...

7. pennstatehealthnews.org pennstatehealthnews.org/2024/04/qa-can-weight-loss-drugs-help-in-addiction-treatment/

Q&A: Can weight loss drugs help in addiction treatment? We saw a 40% reduction in opioid craving among participants who were taking the GLP-1 drugs compared to those who received the placebo.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06994338?term=AREA%5BBasicSearch%5D(tirzepatide)&rank=10

NCT06994338 | Tirzepatide for Alcohol Use Disorder The objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and ...

9. nature.com nature.com/articles/s41591-025-03978-z

A systematic review and meta-analysis of the efficacy and ... Safety outcomes ... Only one phase 2 trial performed on tirzepatide showed promising results in improving MASH and liver fibrosis.