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New treatment option for Opioid Use Disorder
Official title Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
ClinicalTrials.gov ID: NCT06651177
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for opioid use disorder.
Also referred to as Mounjaro, Zepbound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 60 days) during the current treatment episode, be taking ≥ the...
- Must be willing to be assigned by chance 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;
You likely can't join if
- 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...
- have a known history of chronic or acute pancreatitis, gallbladder disease, gastroparesis, gastric emptying abnormality, gastroesophageal reflux...
- 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...
See the full eligibility criteria
- 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 60 days) during the current treatment episode, be taking ≥ the recommended target dose for transmucosal BUP (or equivalent for...
- Must be willing to be assigned by chance 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...
- 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...
- 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...
- 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;
- 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Cape Girardeau, Missouri, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Huntington, West Virginia, United States
- Morgantown, West Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Tampa, Florida, United States; Chicago, Illinois, United States; Cape Girardeau, Missouri, United States; Greenville, South Carolina, United States; Nashville, Tennessee, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.