Opioid Use Disorder Research Study
Researchers are conducting a study in adults with moderate to severe opioid use to understand how tirzepatide, added to buprenorphine treatment, affects treatment outcomes, substance use, and sleep.
Fast Facts
Started buprenorphine in the last two months or planning to start (e.g., Suboxone, Sublocade, Brixadi)
Adults with moderate to severe problems with opioid use
Compensation
provided
Conducted in multiple locations
Study Background
Researchers are studying adults with opioid use to see how tirzepatide affects treatment and health outcomes.
Opioid use disorder, which can involve difficulties with cravings, withdrawal, and staying in treatment, is related to disruptions in daily functioning and overall health. This study aims to learn more about how tirzepatide, when added to buprenorphine treatment, may help improve treatment retention, reduce substance use, and support overall well-being.
Ultimately, the findings of this study could help improve treatment strategies for people with opioid use disorder and enhance their quality of life.
Study Background
Researchers are studying adults with opioid use to see how tirzepatide affects treatment and health outcomes.
Opioid use disorder, which can involve difficulties with cravings, withdrawal, and staying in treatment, is related to disruptions in daily functioning and overall health. This study aims to learn more about how tirzepatide, when added to buprenorphine treatment, may help improve treatment retention, reduce substance use, and support overall well-being.
Ultimately, the findings of this study could help improve treatment strategies for people with opioid use disorder and enhance their quality of life.
Additional Information
In this research study, we are trying to understand how opioid use disorder affects treatment outcomes, cravings, and overall health. We aim to learn how adding tirzepatide to buprenorphine treatment may help people stay in treatment, reduce substance use, and improve sleep and daily functioning. We will measure these effects through regular assessments, questionnaires, and wearable devices like Fitbits. This study will help us understand whether tirzepatide can be an effective addition to standard opioid use treatment.
You may be eligible for this study if you meet the following criteria:
Inclusion Criteria:
- 18 years of age or older
- Experiencing moderate to severe opioid use disorder
- Started or are planning to start a new buprenorphine treatment episode within the past 60 days
- Willing to be randomized to tirzepatide or placebo and participate in weekly study visits
Exclusion Criteria:
- Pregnant or breastfeeding
- Have type 1 or type 2 diabetes
- Have previously taken tirzepatide (Mounjaro® or Zepbound®) or are currently taking other glucose-lowering medications
- History of major cardiovascular events in the past 90 days, chronic or acute pancreatitis, gallbladder disease, GERD, or other severe gastrointestinal conditions
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- Renal impairment
- History of suicide attempts in the past year or current suicidal ideation
The entire study lasts approximately 7 months. Once enrolled, the study involves:
- In-person visits: You will attend 26 weekly visits where you will receive tirzepatide or placebo injections, complete questionnaires and assessments about opioid use, cravings, withdrawal, sleep, and overall health. Some visits will be longer (months 1, 3, and 6) to include extended assessments, and there is a follow-up visit at week 30. You will also be given a Fitbit to track sleep and activity throughout the study.
Site Locations:
- Marshall Univeristy | Huntington, WV
- Prisma Health | Greenville, SC
- Gateway | Jacksonville, FL
- Cook County Health | Chicago, IL
- Gibson Center for Behavioral Change | Cape Giradeau, MO
- University of Utah | Salt Lake City, UT
- WVU Healthy Minds | Morgantown, WV
- Vanderbilt | Nashville, TN
- Tarzana | Tarzana, CA,
- Ibis Healthcare | Tampa, FL
As a participant, you will receive compensation for your time, plus a Fitbit to track your sleep and a study cell phone with service for the duration of the study, both of which you may keep after completing participation.
There is no cost for you to participate in our research study. Participants will be responsible for costs associated with their buprenorphine treatment.