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

May 18, 2026 updated by: T. John Winhusen, PhD

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 receive tirzepatide or placebo based on randomized assignment, with "dose escalation" of placebo following the schedule for tirzepatide and tirzepatide dosing being consistent with prescribing guidelines. 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. A follow-up visit for final safety measures will be completed at week 30, which takes into account tirzepatide's long half-life.

Duration of participation will be approximately 31 weeks for study participants. Participants will be administered study medication and attend weekly research visits through 6 months post-randomization with longer research visits at 1-, 3-, and 6-months post-randomization. Participants will be provided with a Fitbit to measure sleep. BUP is not a study medication; participants will receive BUP through their clinical provider. A follow-up visit for final safety measures will be completed at week 30.

Study Type

Interventional

Enrollment (Estimated)

310

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Gateway Community Services
        • Contact:
        • Contact:
      • Tampa, Florida, United States, 33605
        • Not yet recruiting
        • IBIS Behavioral Health
        • Contact:
    • Illinois
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • The Gibson Center for Behavioral Change
        • Contact:
    • South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Marcela Smid, MD, MS, MA
          • Phone Number: 385-977-2445
          • Email: tab@utah.edu
        • Contact:
          • Kathryn Szczotka
          • Phone Number: 385-977-2445
          • Email: tab@utah.edu
    • West Virginia
      • Huntington, West Virginia, United States, 25701
      • Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Must be ≥18 years of age;
  2. Must have moderate to severe OUD;
  3. 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;
  4. Must be willing to be randomized to tirzepatide or placebo and to comply with study procedures, including weekly visits for 6 months;
  5. Must be able to understand the study, and having understood, provide written informed consent in English;

  6. Must not be breastfeeding; if of child bearing potential, must test negative on the study-administered pregnancy test(s), and if of childbearing potential and engaging /planning to engage in sexual intercourse must agree to effective contraception for the duration of the trial through 30 days after the trial; effective contraception is defined as using: a) birth control injection, an intrauterine device, or implant; or b) two birth control methods - for example birth control pills with a barrier method (e.g., condoms, etc.).

    • If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:

      1. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, tubal implants, or tubal ligation), congenital anomaly such as Mullerian agenesis; are
      2. post-menopausal defined as ≥ 55 years old not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea;
      3. ≥ 55 years old with a diagnosis of menopause prior to starting hormone replacement therapy; or
      4. ≥ 40 years old with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone ≥ 40 mIU/mL; participants in this category must test negative on the study-administered pregnancy test(s).

Exclusion Criteria:

  1. have a history of type 1 or type 2 diabetes mellitus (other than pregnancy-related diabetes);
  2. have a BMI <23.0 kg/m²;
  3. 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);
  4. have a known history of chronic or acute pancreatitis, gallbladder disease, gastroparesis, gastric emptying abnormality, gastroesophageal reflux disease, or other severe gastrointestinal disease;
  5. have a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
  6. have previously taken tirzepatide, have taken any GLP-1 analogue within the 6 months before consent, or have a known history of prior hypersensitivity reaction to any GLP-1 analogue;
  7. have renal impairment defined as an estimated glomerular filtration rate (eGFR) value of < 15 mL/min/1.73 m2 or requiring dialysis;

  8. have a current, or within the 30 days prior to signing consent, use of, or plan to start during the course of the trial:

    1. medications with glucose lowering properties: GLP-1 analogs, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors;
    2. systemic steroids including prednisone, hydrocortisone, dexamethasone;
  9. have a history of suicide attempts in the prior year or significant active suicidal ideation as assessed by a qualified study clinician;
  10. have a psychiatric or medical condition that, in the judgment of the site medical clinician (BMC or UMC), would make study participation unsafe or which would make treatment compliance difficult;
  11. have current status as a prisoner OR be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
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.
Drug: Tirzepatide
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
Other Names:
  • Mounjaro
  • Zepbound
Placebo Comparator: Placebo
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.
Other: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-month retention in BUP treatment
Time Frame: 6 months
MOUD is defined as buprenorphine (BUP). The receipt of BUP will be assessed thorough self-report collected through a Timeline Follow-Back (TLFB) procedure and will be partially verified through urine drug screens.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Effectiveness
Time Frame: 6 months
Treatment Effectiveness will be measured by the Treatment Effectiveness Assessment (TEA). The TEA is a patient-oriented instrument that assesses the participant's perceived improvements in substance use, health, ability to fulfill adult obligations, and to be a good community member. The TEA includes four items, each rated on a 1-10-point scale (from none to much better) yielding a total score of 4-40.
6 months
Sleep Quality - Fitbit Charge 6™ (FBC-6)
Time Frame: 6 months
An objective measure of the impact of tirzepatide, relative to placebo, on sleep will be obtained using the Fitbit Charge 6™ (FBC-6). A comparison of an earlier version of the device (Fitbit Charge 4™) to polysomnography found no significant differences in the measures of total sleep time and waking after sleep onset. Each participant will be provided with a Fitbit Charge 6™ when they are deemed eligible for randomization and asked to wear it every night (or whenever they have their longer period of intended sleep) through the final study visit. Data from the Fitbit Charge 6™ will be downloaded at the weekly research visits. Total sleep time is the main outcome of interest.
6 months
Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 6 months
Participant perceived sleep quality will be assessed using the PSQI, which is a relatively brief, validated instrument that measures sleep quality.
6 months
Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase
Time Frame: 6 Months
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Illicit opioid-negative UDSs are defined as being negative for fentanyl, opiates, oxycodone, and methadone (unless the participant starts methadone treatment).
6 Months
Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol
Time Frame: 6 months
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Negative urine samples are defined as being negative for: cocaine, methamphetamine, amphetamine, marijuana, benzodiazepines, methylenedioxymethamphetamine, barbiturates, phencyclidine, and ethyl glucuronide.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic-related outcomes - A1C
Time Frame: 6 months
Blood samples to assess A1C will be obtained at baseline, month 3, and month 6. Mean change in A1C (%) is the outcome of interest.
6 months
Metabolic-related outcomes - Body Mass Index (BMI)
Time Frame: 6 months
Height will be measured at screening/baseline and weight will be measured. Body mass index (BMI) will be calculated with mean change in BMI (kg/m2) as the outcome of interest.
6 months
Metabolic-related outcomes - Weight
Time Frame: 6 months
Weight will be measured. Mean change in weight (kg) is the outcome of interest.
6 months
Metabolic-related outcomes - % Weight loss
Time Frame: 6 months
Weight will be measured. Proportion of weight loss (kg) is the outcome of interest.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T. John Winhusen, PhD

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: T. John Winhusen, PhD., University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1003
  • UG1DA013732 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant-level data gathered from case report forms.

IPD Sharing Time Frame

June 30, 2028 (anticipated)

IPD Sharing Access Criteria

Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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