The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).
English-speaking
Age 18 years-old or older
Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
Initiating or continuing buprenorphine for treatment of opioid use disorder
Previous enrollment in the trial
Incarcerated or in police custody*
Pregnant
Live outside of Rhode Island (RI)
Parallel
Buprenorphine
DrugBuprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.
Treatment Engagement
The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply.
Control of Opioid Cravings
Measured using patient reported outcomes via the Opioid Craving Scale, a reliable, validated scale for people with opioid use disorder. The scale consists of three questions related to opioid cravings rated on a scale of 1-10 with 1 being not at all and 10 being extremely. A higher score denotes increased opioid cravings.
Treatment response based on use of non-prescribed opioids
Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens including fentanyl (UDS) and self-report. UDS will be assessed monthly for six months after study enrollment. Self-reported will be assessed at 1, 3, and 6 months via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid/fentanyl over the preceding two weeks. Based on UDS and self-reported data, participants will be classified as treatment responders if they have (1) no evidence (negative UDS and negative self-report) of non-prescribed opioid use at ≥1 assessment in months 1 to 3 AND (2) no evidence of non-prescribed opioid use at ≥2 assessments in months 4 to 6.
Rate of Non-fatal or Fatal Opioid Overdose
Non-fatal and fatal opioid overdoses will be assessed using statewide data from the Rhode Island Department of Health, including the Emergency Medical Services (EMS) Information System, Opioid Overdose Reporting System (OORS), and Office of the State Medical Examiners (OSME). All of these systems report non-fatal or fatal opioid overdoses which investigators will aggregate to arrive at the rate of non-fatal or fatal opioid overdoses.
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
Brown University
Collaborator
