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
This trial does not accept healthy volunteersQualifiers
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 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;
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
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugThe 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
Placebo
Other interventionSaline 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.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
6 monthsSecondary outcomes
1
Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Illicit opioid-negative UDSs are defined as being negative for fentanyl, opiates, oxycodone, and methadone (unless the participant starts methadone treatment).
Time frame
6 Months2
Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Negative urine samples are defined as being negative for: cocaine, methamphetamine, amphetamine, marijuana, benzodiazepines, methylenedioxymethamphetamine, barbiturates, phencyclidine, and ethyl glucuronide.
Time frame
6 months3
Treatment Effectiveness
Treatment Effectiveness will be measured by the Treatment Effectiveness Assessment (TEA). The TEA is a patient-oriented instrument that assesses the participant's perceived improvements in substance use, health, ability to fulfill adult obligations, and to be a good community member. The TEA includes four items, each rated on a 1-10-point scale (from none to much better) yielding a total score of 4-40.
Time frame
6 months4
Sleep Quality - Fitbit Charge 6™ (FBC-6)
An objective measure of the impact of tirzepatide, relative to placebo, on sleep will be obtained using the Fitbit Charge 6™ (FBC-6). A comparison of an earlier version of the device (Fitbit Charge 4™) to polysomnography found no significant differences in the measures of total sleep time and waking after sleep onset. Each participant will be provided with a Fitbit Charge 6™ when they are deemed eligible for randomization and asked to wear it every night (or whenever they have their longer period of intended sleep) through the final study visit. Data from the Fitbit Charge 6™ will be downloaded at the weekly research visits. Total sleep time is the main outcome of interest.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
T. John Winhusen, PhD
Lead sponsor
University of Cincinnati
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov