Original Investigation

Comparison of Extended-Release Buprenorphine Doses for Treating High-Risk Opioid Use

JAMA Network Open 10.1001/jamanetworkopen.2025.48043

December 17, 2025 at 11:00 AM EST

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How do the efficacy and safety compare between 100-mg and 300-mg once-monthly extended-release buprenorphine doses for individuals with high-risk opioid use, including fentanyl?In this randomized clinical trial including 436 participants with moderate to severe opioid use disorder, both the 100-mg and 300-mg maintenance doses improved opioid abstinence and were well tolerated without any new safety signals. In post hoc analyses, the 300-mg dose performed better than the 100-mg dose among participants who used fentanyl daily, 14 times or more per week, or both.These findings demonstrate that both 100-mg and 300-mg extended-release buprenorphine doses improved opioid abstinence among patients at high risk; the 300-mg maintenance dose may perform better for individuals with heavy fentanyl use.

Corresponding Author: Robert L. Dobbins, MD, PhD, Research and Development, Indivior Inc, 10710 Midlothian Turnpike, Ste 125, North Chesterfield, VA 23235 (robert.dobbins@indivior.com).

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