Pregabalin plus lofexidine to help people switch to monthly naltrexone
Official title: Combining Pregabalin with Lofexidine: Can it Increase the Success of Transition to Naltrexone?
Funded at University of Pennsylvania · NIH-11177815 · Data updated 2026-11-12
This project tries adding pregabalin to lofexidine to help adults with opioid dependence complete detox and begin extended‑release naltrexone.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Pennsylvania NIH-funded |
| Lab location | 1 site (Philadelphia, United States) |
| Project start | September 30, 2019 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $2,584,873 |
| NIH project number | 5UH3DA049694-04 |
| Project ID | NIH-11177815 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults with opioid use disorder who want to stop opioids and transition to extended‑release naltrexone (and who have no contraindication to pregabalin or lofexidine) would be the ideal candidates.
✕Less likely to help
People who prefer or need agonist maintenance (methadone or buprenorphine), who are pregnant, or who cannot take pregabalin or lofexidine may not benefit from this approach.
What this research studies
If you have opioid dependence and want to switch to monthly naltrexone, the team will test whether adding pregabalin to lofexidine makes the detox process easier and speeds the move onto naltrexone. Participants will receive medication during the detox period and researchers will track withdrawal symptoms, cravings, and whether people successfully start extended‑release naltrexone. The project builds on prior small trials and uses randomized, blinded methods to compare outcomes between groups. Study staff will follow participants after detox to measure relapse, retention, and safety.
Why it matters
Potential benefit: If successful, this approach could increase the number of people who complete detox and start extended‑release naltrexone, potentially lowering relapse and overdose risk.
How similar studies have gone: Small randomized trials and observational reports have suggested pregabalin can ease opioid withdrawal and lofexidine shortens detox, but combining pregabalin with lofexidine for improving transition to naltrexone remains relatively novel and needs larger testing.
Where this research is happening
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University of Pennsylvania
Philadelphia, United States Active
Researchers
- Principal investigator: Kampman, Kyle Matthew — University of Pennsylvania
- Study coordinator: Kampman, Kyle Matthew
Related research
Other NIH-funded projects on the same topics.
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Combining two medications to help patients transition to naltrexone for opioid addiction.
This study is looking at whether taking pregabalin along with lofexidine can help people with opioid addiction have an easier time starting naltrexone, a medication that helps them stay off opioids, by making withdrawal symptoms less intense and reducing the chance of relapse.
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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.