Standard Versus High Dose ED-Initiated Buprenorphine Induction
Start Date
12/6/2024
Completion Date
12/1/2028
Summary
This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.
Detailed Description
This study will recruit, train, and provide resources to approximately 4 ED systems throughout the U.S. to recruit ED patients presenting with OUD not receiving medications for opioid use disorder (MOUD) as part of an RCT to compare SDI (Zubsolv 5.7/1.4 mg buprenorphine/naloxone\* plus 2 placebo tablets) with HDI (three Zubsolv 5.7/1.4 mg\* buprenorphine/naloxone tablets) to evaluate rate of participation in OUD treatment within 10 days post-randomization and differences in outcomes of tolerability, opioid withdrawal symptoms, craving, and use of illicit drugs.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
Buprenorphine
Conditions
Locations
Highland Hospital
Oakland, California 94602
United States
San Leandro Hospital
San Leandro, California 94578
United States
Maine Medical Center
Portland, Maine 04102
United States
Cooper University Hospital
Camden, New Jersey 08103
United States
University of Utah Hospital
Salt Lake City, Utah 84132
United States