TAB: A National Multi-Site Research Study
A groundbreaking national research study is seeking participants who have recently started medication for opioid use disorder.
Fast Facts
Adults Who Have Problems with Opioid Use
Starting or Planning To Start Buprenorphine
Compensation
Provided
Studying Tirzepatide vs. Placebo
Study Background
Does tirzepatide make it easier to stay on buprenorphine treatment for opioid use disorder?
We are conducting a research study to find out if adding tirzepatide to buprenorphine treatment is useful in treating opioid use disorder. We want to know if it can help people with opioid use disorder stay in treatment, reduce cravings and substance use, and improve sleep when used alongside buprenorphine (brand names include Suboxone®, Zubsolv®, Brixadi®, and Sublocade®).
Tirzepatide – a medication currently approved for type 2 diabetes (Mounjaro®) and weight management (Zepbound®) – is not currently FDA-approved for treating opioid use disorder. Participants will be randomly assigned to tirzepatide or placebo. Participation is completely voluntary.
We believe this research study offers participants an opportunity to not only help themselves, but also to be a part of determining the best ways of helping others in similar situations. If you have recently started medication for opioid use disorder, you could be eligible for this important study.
Study Background
Does tirzepatide make it easier to stay on buprenorphine treatment for opioid use disorder?
We are conducting a research study to find out if adding tirzepatide to buprenorphine treatment is useful in treating opioid disorder. We want to know if it can help people with opioid use disorder stay in treatment, reduce cravings and substance use, and improve sleep when used alongside buprenorphine (brand names include Suboxone®, Zubsolv®, Brixadi®, and Sublocade®).
Tirzepatide – a medication currently approved for type 2 diabetes (Mounjaro®) and weight management (Zepbound®) – is not currently FDA-approved for treating opioid use disorder. Participants will be randomly assigned to tirzepatide or placebo. Participation is completely voluntary.
We believe this research study offers participants an opportunity to not only help themselves, but also to be a part of determining the best ways of helping others in similar situations. If you have recently started medication for opioid use disorder, you could be eligible for this important study.
Study Sites
Additional Information
Buprenorphine is a front-line treatment for opioid use disorder, but it works best over the long term, and treatment retention (staying on the medication) can be difficult. The purpose of this research study is to find out whether adding tirzepatide to buprenorphine treatment has an effect on staying in treatment, substance use/craving, and sleep in individuals with opioid use disorder.
Tirzepatide is marketed as:
- Mounjaro®, which is approved by the FDA for type 2 diabetes.
- Zepbound®, which is approved by the FDA for weight management.
In both products, tirzepatide is administered with a small needle (subcutaneous injection under the skin). Tirzepatide is not approved by the FDA for use in combination with buprenorphine treatment; one of the aims of this study is to find out what effects (good and bad) tirzepatide has on the participants and their buprenorphine treatment for opioid use disorder.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Adults with moderate to severe problems with opioid use
- Newly started (within the past 28 days) or planning to start treatment with buprenorphine (e.g., Suboxone, Sublocade, Brixadi)
- Willing to attend 26 weekly visits
- Not currently pregnant or breastfeeding
- Have not previously taken tirzepatide (e.g., Mounjaro, Zepbound)
- Do not have type 1 or 2 diabetes
- Willing to use effective birth control during the study’s duration
- 18 years or older
Your participation in the study would last about 31 weeks.
This would include about:
- 1 week for screening and baseline assessments
- 26 weeks of active treatment with either tirzepatide or a placebo (“fake” treatment)
- one follow up visit at about study week 30
In all, you will attend about 28 visits. Three of these visits, which will occur at study months 1, 3, and 6, will be longer than the usual weekly visits. Your participation would be entirely voluntary.
Yes, you will be compensated for time & travel. As part of the study, you will also receive a FitbitTM and a cell phone; if you are randomized, you will be allowed to keep these devices after your study participation concludes.
There is no cost for you to participate in our research study.