Combining buprenorphine with extended-release naltrexone to prevent opioid relapse
Official title: Efficacy of buprenorphine and XR-naltrexone combination for relapse prevention in opioid use disorder
Funded at New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC · NIH-10861050 · Data updated 2026-11-12
This project checks whether adding daily buprenorphine to monthly extended‑release naltrexone helps people with opioid use disorder stay off opioids.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project start | August 1, 2020 |
| Project end | April 30, 2028 |
| Funding year | 2026 |
| Award (this year) | $695,203 |
| NIH project number | 5U01DA046430-04 |
| Project ID | NIH-10861050 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with opioid use disorder who are eligible for extended‑release naltrexone, including those who have had difficulty with or prefer alternatives to buprenorphine maintenance, would be the ideal candidates.
✕Less likely to help
People who are already stable and doing well on buprenorphine maintenance or those with medical contraindications to either buprenorphine or naltrexone are less likely to benefit from this approach.
What this research studies
If you join, you would receive monthly extended‑release naltrexone and, in addition, daily buprenorphine to see if the combination keeps people in treatment longer. The approach is meant for people who want to avoid long‑term opioid agonist maintenance or who have not done well on buprenorphine alone. Researchers will follow participants over time to track treatment retention, opioid use, and side effects. The team aims to compare how well the combination works versus current approaches to prevent relapse.
Why it matters
Potential benefit: If successful, this approach could help more people stay in treatment longer and reduce opioid relapse and overdose risk.
How similar studies have gone: Both buprenorphine and XR‑naltrexone are used in OUD treatment, XR‑naltrexone has had modest retention (~50%), and combining the two is a novel strategy currently being tested.
Where this research is happening
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New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC
New York, United States Active
Researchers
- Principal investigator: Bisaga, Adam — New York State Psychiatric Institute Dba Research Foundation for Mental Hygiene, INC
- Study coordinator: Bisaga, Adam
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.