Could a diabetes drug help fight opioid addiction?
NCT ID NCT06651177
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This study tests whether tirzepatide, a drug used for diabetes and weight loss, can help people with moderate to severe opioid use disorder stay in treatment and use fewer opioids when added to their regular buprenorphine medication. About 310 adults who recently started buprenorphine will receive either tirzepatide or a placebo for 6 months. The goal is to see if tirzepatide improves treatment retention and reduces opioid use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 310 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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; 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gateway Community Services
RECRUITINGJacksonville, Florida, 32204, United States
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Healthy Minds/Chestnut Ridge
RECRUITINGMorgantown, West Virginia, 26505, United States
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IBIS Behavioral Health
RECRUITINGTampa, Florida, 33605, United States
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Marshall Health
RECRUITINGHuntington, West Virginia, 25701, United States
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Prisma Health
RECRUITINGGreenville, South Carolina, 29605, United States
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Ruth M. Rothstein CORE Center
RECRUITINGChicago, Illinois, 60612, United States
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The Gibson Center for Behavioral Change
RECRUITINGCape Girardeau, Missouri, 63703, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84108, United States
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Vanderbilt University Medical Center
RECRUITINGNashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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