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.

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

Assistant Professor of Emergency Medicine

Yale School of Medicine

333 Cedar St, New Haven, CT, 06510, US

kathryn.hawk@yale.edu

Andrew Herring, M.D.

Assistant Clinical Professor, UCSF and Associate Director of Research

Highland Hospital-Alameda Health System

1411 East 31st Street, Oakland, CA, 94602, US

aherring@alamedahealthsystem.org

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, US

gail.donofrio@yale.edu

CTN-0145 active