Glucagon-like peptide 1 (GLP-1) receptor agonist drugs have been on the forefront as a promising treatment for multiple health issues — specifically in the management of type 2 diabetes and weight management.
Vanderbilt Health has opened enrollment in a national, multi-site research study in hopes of determining if the addition of the Food and Drug Administration-approved medication can also help people with opioid use disorder (OUD).
Jessica Young, MD, MPH, Associate Professor of Clinical Obstetrics and Gynecology at Vanderbilt Health and Medical Director of Firefly, a comprehensive care and treatment program for pregnant and postpartum women with substance use disorder and their children, will serve as the study’s principal site investigator. The study will include both females and males.
OUD, a chronic condition that causes significant distress or harm to a person’s daily life, affects more than 2 million people in the United States.
“There is a critical need to address treatment options for all individuals with OUD,” said Young. “Opioid use disorder is a chronic disease where relapse is common. Finding ways to prevent relapse for both men and women is lifesaving.”
There are approximately 2,500 fatalities annually in Tennessee due to overdose, with opioids causing 80% of these deaths.
The study, Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder (TAB), is a double-blind, randomized, placebo-controlled trial conducted through the National Institute on Drug Abuse’s Clinical Trials Network.
Participant requirements:
- Must be at least 18 years old
- Have moderate to severe OUD
- Must have started buprenorphine treatment for OUD within the past 80 days
Vanderbilt Health hopes to enroll about 31 people during the trial which will include weekly research visits during a six-month period for an injection of the GLP-1 medication tirzeptide or placebo and wearing a trial-issued Fitbit to help track sleep data. Participants will also receive a cell phone to track the Fitbit data and be compensated for time and travel.
“We hope to find that adding a GLP-1 to treatment plans will help people stabilize on buprenorphine therapies and prevent relapse,” said Young. “This could change the standard of care if it improves outcomes and decreases relapse.”
For more information on the study, call 615-587-9669 or email vumc.ctn152tab@vumc.org.
