RENEW-OP-1
The RENEW-Op-1 study is evaluating the safety and effectiveness of brenipatide compared with placebo in individuals with opioid use disorder receiving treatment with buprenorphine, with or without naloxone.
About This Study
Summary
This study is evaluating whether brenipatide is safe and effective for people with opioid use disorder (OUD), when added to standard treatment with buprenorphine, with or without naloxone.
Participants in this study will receive brenipatide while continuing their background treatment with buprenorphine-based therapy.
This site is participating only in Part B, the open-label portion of the study. In an open-label study, all participants receive the study drug, and both participants and researchers know which treatment is being given.
Total participation may last up to approximately 2 years, depending on the study part and when a participant enrolls. Timing may vary from person to person.
Study medication is given alongside standard care with buprenorphine with or without naloxone.
To be included in RENEW-OP-1, participants must be / have
- 18 – 75 years of age
- Have a diagnosis of OUD
- Taking transmucosal buprenorphine
- Willing to comply with all study assessments and procedures
To be included in RENEW-OP-1, participants must not be / have
- Diagnosed schizophrenia, bipolar disorder, borderline personality disorder, or eating disorder
- Opioid overdose in past 6 months
- Current substance use disorder (excluding OUD)
- Pregnant or breastfeeding or planning to become pregnant/breastfeed
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Dr. Albert Arias is a psychiatrist with more than 25 years of clinical and research experience. He's a professor at Virginia Tech Carilion School of Medicine. He's board certified by the American Board of Psychiatry and Neurology in Psychiatry. He completed his residency at the University of Connecticut Health.
Official title of study
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study with a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine with or without Naloxone in Early Recovery of Participants with Opioid Use Disorder (RENEW-Op-1)
Funding mechanism
Industry sponsored by Eli Lilly and Company