Opioid Use DisorderPhase 2TABNCT06651177
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
A Phase 2 study testing Tirzepatide in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by T. John Winhusen, PhD at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 9 sitesUnited States
- Study dates
- 29 Jan 2026to 31 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 80 days) during the current treatment episode, be taking ≥ 8 mg/day of generic buprenorphine-naloxone film/tablets (or the equivalent for other buprenorphine products), 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;
- 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.).
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- If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:
- infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, tubal implants, or tubal ligation), congenital anomaly such as Mullerian agenesis; are
- post-menopausal defined as ≥ 55 years old not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea;
- ≥ 55 years old with a diagnosis of menopause prior to starting hormone replacement therapy; or
- ≥ 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).
Who cannot join
- 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);
- 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;
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- have renal impairment defined as an estimated glomerular filtration rate (eGFR) value of < 15 mL/min/1.73 m2 or requiring dialysis;
- have a current, or within the 30 days prior to signing consent, use of, or plan to start during the course of the trial:
- 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;
- systemic steroids including prednisone, hydrocortisone, dexamethasone;
- have a history of suicide attempts in the prior year or significant active suicidal ideation as assessed by a qualified study clinician;
- 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;
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
The Gibson Center for Behavioral Change
Cape Girardeau, Missouri, 63703
Ashley Naeger, 573-803-4158, naegera@gibsonrecovery.org
- Recruiting
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
Pamela Vergara-Rodriguez, MD, 312-572-4753, pamela.vergara@cookcountyhhs.org
Mireya Gonzalez, 312-572-4555, mireya.gonzalez@cookcountyhealth.org
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Alain Litwin, MD, 864-430-0911, alain.litwin@prismahealth.org
Anthony Faso, 864-455-1584, anthony.faso@prismahealth.org
- Recruiting
Marshall Health
Huntington, West Virginia, 25701
Zachary Hansen, MD, 304-696-8700, hansen8@marshall.edu
Lacey Andrews, 304-691-6404, andrews29@marshall.edu
- Recruiting
Gateway Community Services
Jacksonville, Florida, 32204
Candace Hodgkins, PhD., 904-387-4661, chodgkins@gwjax.com
Joseph Seim, 904-387-4661, jseim@gwjax.com
- Recruiting
Healthy Minds/Chestnut Ridge
Morgantown, West Virginia, 26505
Laura Lander, MSW, LICSW, 304-293-3965, llander@hsc.wvu.edu
Michelle Chisester, michelle.chidester@hsc.wvu.edu
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Jessica L Young, MD, 615-585-9889, jessica.l.young@vumc.org
Stephanie Hartwig, 615-875-0578, stephanie.m.hartwig@vumc.org
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Marcela Smid, MD, MS, MA, 385-977-2445, tab@utah.edu
Kathryn Szczotka, 385-977-2445, tab@utah.edu
- Recruiting
IBIS Behavioral Health
Tampa, Florida, 33605
Alexander Sinu, MD, 813-384-4000, asinu@ibishc.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Tirzepatide, Placebo
- Keywords
- tirzepatide, opioid, opioid use disorder, buprenorphine, GLP-1
- Medical subject headings
- Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro, Zepbound
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
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | 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. Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month retention in BUP treatment
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.
Measured: 6 months
Secondary outcomes (5)
Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase
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).
Measured: 6 Months
Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol
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.
Measured: 6 months
Treatment Effectiveness
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.
Measured: 6 months
Sleep Quality - Fitbit Charge 6™ (FBC-6)
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.
Measured: 6 months
Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI)
Participant perceived sleep quality will be assessed using the PSQI, which is a relatively brief, validated instrument that measures sleep quality.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start29 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T. John Winhusen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, T. John Winhusen, PhD, University of Cincinnati
- Investigators
- T. John Winhusen, PhD., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651177
- Sponsor's protocol ID
- 2024-1003
- Other IDs
- UG1DA013732
- Acronym
- TAB
- Status last verified
- May 2026
- First submitted
- 17 Oct 2024
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data gathered from case report forms.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06651177
- Acronym / sponsor ID
- TAB / 2024-1003
- Keywords
- tirzepatide, opioid, opioid use disorder, buprenorphine, GLP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- T. John Winhusen, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideThe 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. |
| Placebo | Placebo comparator | Other: PlaceboSaline 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 80 days) during the current treatment episode, be taking ≥ 8 mg/day of generic buprenorphine-naloxone film/tablets (or the equivalent for other buprenorphine products), 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 (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: Mounjaro, ZepboundThe 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 | Drug | Tirzepatide |
| PlaceboSaline 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 |
Primary outcome
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.
5 secondary outcomes
Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase
Time frame: 6 Months
Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol
Time frame: 6 months
Treatment Effectiveness
Time frame: 6 months
Sleep Quality - Fitbit Charge 6™ (FBC-6)
Time frame: 6 months
Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data gathered from case report forms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
T. John Winhusen, PhD. principal investigator
University of Cincinnati
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by T. John Winhusen, PhD at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frankie B Kropp, MS, LICDC (513-585-8290, kroppfb@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month retention in BUP treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.