Standard versus High Dose ED-Initiated Buprenorphine Induction (NIH HEAL Initiative)

Funded by the NIH HEAL Initiative®

This is a multisite, randomized double-blind, double-dummy, clinical trial of ED patients with moderate to severe OUD (N=320) to compare buprenorphine High Dose Induction (HDI; 24 mg) and buprenorphine Standard ED Dose Induction (SDI; 8 mg) to evaluate potential differences between HDI and SDI on the outcomes of craving, tolerability, safety, withdrawal symptoms, and illicit drug use assessed for 7 days post-randomization. The study will evaluate potential difference in rates of engagement in follow-up OUD treatment within 1-week post-randomization between the HDI and SDI participants. The study will also evaluate outcomes based on other substance use (i.e., fentanyl, stimulants, sedatives), race, housing instability and other social determinants of health.

CTN Protocol ID: 
CTN-0145
Status: 
Development

Principal Investigator(s)

Kathryn Hawk, M.D., M.H.S.

Assistant Professor of Emergency Medicine
Yale School of Medicine

333 Cedar St
New Haven, CT 06510
United States

Andrew Herring, M.D.

Assistant Clinical Professor, UCSF and Associate Director of Research
Highland Hospital-Alameda Health System
Department of Emergency Medicine

1411 East 31st Street
Oakland, CA 94602
United States

Gail D'Onofrio, M.D., M.S.

Professor of Emergency Medicine
Yale University School of Medicine
Chair, Department of Emergency Medicine

464 Congress Avenue
Suite 260
New Haven, CT 06519
United States