Actively Recruiting
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Led by T. John Winhusen, PhD · Updated on 2026-05-14
310
Participants Needed
10
Research Sites
91 weeks
Total Duration
On this page
Sponsors
T
T. John Winhusen, PhD
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older
- Must have moderate to severe opioid use disorder
- Must be newly started on buprenorphine treatment within 7 to 60 days of the current treatment episode
- Must be taking at least the recommended target dose for transmucosal buprenorphine or equivalent for extended-release
- Must have documentation from their buprenorphine provider of dose and start date for current treatment
- For transmucosal buprenorphine users, must have at least one urine drug screen positive for buprenorphine/norbuprenorphine
- Must be willing to be randomized to tirzepatide or placebo and comply with study procedures including weekly visits for 6 months
- Must understand the study and provide written informed consent in English
- Must not be breastfeeding
- If of childbearing potential, must test negative on study pregnancy tests and agree to use effective contraception during the trial and for 30 days after
- Participants are considered not of childbearing potential if infertile due to surgery, congenital anomaly, post-menopausal as defined, or meet specific hormonal criteria with negative pregnancy test
You will not qualify if you...
- History of type 1 or type 2 diabetes mellitus (except pregnancy-related diabetes)
- Body mass index (BMI) less than 23.0 kg/m²
- Cardiovascular events within 90 days before consent including heart attack, stroke, unstable angina, or hospitalization for congestive heart failure
- History of severe gastrointestinal diseases such as pancreatitis, gallbladder disease, gastroparesis, gastric emptying problems, or severe reflux
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Prior use of tirzepatide or any GLP-1 analogue within 6 months before consent, or known allergy to GLP-1 analogues
- Renal impairment with very low kidney function or requiring dialysis
- Current or recent (within 30 days) use or planned use during the trial of glucose-lowering medications or systemic steroids
- History of suicide attempts in the past year or significant active suicidal thoughts
- Medical or psychiatric conditions that make participation unsafe or treatment compliance difficult
- Current prisoner status or involvement in legal situations that could prevent study participation
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Tarzana Treatment Centers
Tarzana, California, United States, 91356
Not Yet Recruiting
2
Gateway Community Services
Jacksonville, Florida, United States, 32204
Actively Recruiting
3
IBIS Behavioral Health
Tampa, Florida, United States, 33605
Not Yet Recruiting
4
Ruth M. Rothstein CORE Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
The Gibson Center for Behavioral Change
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
6
Prisma Health
Greenville, South Carolina, United States, 29605
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
9
Marshall Health
Huntington, West Virginia, United States, 25701
Actively Recruiting
10
Healthy Minds/Chestnut Ridge
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
F
Frankie B Kropp, MS, LICDC
CONTACT
B
Benjamin T Kropp, MSLS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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