Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorT. John Winhusen, PhD
About this trial
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.
Eligibility criteria
Qualifiers
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 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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Tirzepatide
- Placebo
Treatment groups
310 Participants
are divided into 2 treatment groupsSponsors and collaborators
T. John Winhusen, PhD
Lead sponsor
University of Cincinnati
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov