Brown University researchers launched a clinical trial comparing two buprenorphine maintenance doses in patients with opioid use disorder who use fentanyl. 

In the study, a 12-month trial published in BMJ Open, the researchers plan to enroll 250 adults in Rhode Island across four outpatient clinics. The participants will be randomly assigned to either 24 mg or 16 mg daily doses, with providers permitted to adjust doses as needed for safety. Eligibility criteria includes moderate-to-severe opioid use disorder (OUD) (DSM-5) and recent fentanyl use confirmed via urine screening or self-report. Pregnant individuals are excluded because of pharmacokinetic considerations.

Primary outcomes will focus on treatment retention at 6 months using statewide administrative data. Secondary outcomes will assess nonprescribed opioid use and cravings, while nonfatal and fatal overdoses will be exploratory endpoints.

Rhode Island ranked 17th in United States opioid overdose mortality in 2022, with fentanyl accounting for over 70% of deaths since 2016. This trial will seek to provide evidence on optimal dosing amidst the fentanyl crisis. Results are expected by mid-2026, funded by the National Institute on Drug Abuse.

The authors disclosed no competing interests.