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

NCT06651177 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1003UG1DA013732
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe; Opioid Use Disorder

Keywords

tirzepatide; opioid; opioid use disorder; buprenorphine; GLP-1

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase

  6 Months

• Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol

  6 months

• Treatment Effectiveness

  6 months

• Sleep Quality - Fitbit Charge 6™ (FBC-6)

  6 months

• Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI)

  6 months

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Tirzepatide DRUG

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

Also known as: Mounjaro, Zepbound

Tirzepatide

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 35 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;
• 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.).
• 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).

You may not qualify if:

• have a history of type 1 or type 2 diabetes mellitus (other than pregnancy-related diabetes);
• have a BMI \<25.0;
• 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;
• 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.

Sponsors & Collaborators

• T. John Winhusen, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (10)

Tarzana Treatment Centers

Tarzana, California, 91356, United States

NOT YET RECRUITING

Gateway Community Services

Jacksonville, Florida, 32204, United States

RECRUITING

IBIS Behavioral Health

Tampa, Florida, 33605, United States

NOT YET RECRUITING

Ruth M. Rothstein CORE Center

Chicago, Illinois, 60612, United States

RECRUITING

The Gibson Center for Behavioral Change

Cape Girardeau, Missouri, 63703, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29605, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Marshall Health

Huntington, West Virginia, 25701, United States

RECRUITING

Healthy Minds/Chestnut Ridge

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Lymphoma, Follicular

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• T. John Winhusen, PhD.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frankie B Kropp, MS, LICDC

CONTACT

513-585-8290; kroppfb@ucmail.uc.edu

Benjamin T Kropp, MSLS

CONTACT

513-585-8287; kroppbn@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor; Vice Chair and Division Director of Addiction Sciences

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: January 29, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: June 30, 2028 (anticipated)
• 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/.

Locations

US (10)