Project Summary/Abstract Excessive alcohol consumption is the third leading preventable cause of death in the U.S. and responsible for 2.7 million years of potential life lost annually. Emergency departments (EDs) provide care for patients with AUD experiencing a variety of alcohol related and unrelated health problems, including illness and injury. Thus, the ED encounter presents a unique opportunity to screen, enhance motivation, initiate medication treatment, and refer to continuation care patients who both seek and do not seek AUD treatment. While combined pharmacological and behavioral therapies for alcohol use disorder (AUD) have demonstrated efficacy in specialty and primary care settings, their effectiveness in the ED setting is unknown, and EDs do not routinely provide comprehensive interventions for AUD. The proposed open label randomized clinical trial (RCT) will evaluate two ED-based intervention models to increase AUD treatment provision and patient engagement. ED patients with moderate to severe AUD (N=240) will be randomly assigned to: (1) Screening, Brief Intervention and Referral to Treatment (SBIRT) (n=120); or (2) SBIRT with ED-initiated medications for AUD (SBIRT+ED- MAUD) (n=120). Gabapentin and extended release or oral naltrexone will be offered as a combination pharmacotherapy in the ED-MAUD component. SBIRT intervention in both study arms will utilize a facilitated referral with direct linkage to continuation AUD treatment following the ED visit. The primary outcome measure will be the rate of AUD treatment engagement assessed on day 30 post randomization in each of the two study groups (Aim 1). The study will also evaluate the between-group difference in the reductions of heavy drinking days from 30 days prior to 30 days post randomization (Aim 2). A statistically significant effect on the primary outcome and a clinically meaningful effect on the reductions of heavy drinking days favoring the SBIRT+ED- MAUD are hypothesized. All enrolled patients will be followed daily on days 1-7 using a brief electronic survey to assess their alcohol cravings, withdrawal symptoms and medication adherence, and with comprehensive follow-up assessments at 30- and 90-days post randomization. The primary outcome, AUD treatment engagement on day 30 post the ED visit, will be based on clinical records documentation obtained from the AUD treatment provider. Alcohol consumption outcomes, medication adherence, the intensity of alcohol cravings and withdrawal symptoms, and other important study outcomes will be based on patient self-report using validated assessment instruments. The planned study sample and the proposed analytical methods will allow for additional meaningful exploratory evaluations of potential differential effects of gender, race, ethnicity, insurance types, and housing instability on the evaluated outcomes. No prospective studies of ED-initiated MAUD interventions have been reported. If successful, the proposed study will provide critically important evidence needed to support a broader dissemination of ED-based interventions for AUD, including MAUD.

Project Narrative The emergency department (ED) provides care for patients with alcohol use disorders (AUD) and a variety of problems including illness, injury, or alcohol-related complication, creating a unique environment to intervene, enhance motivation, and initiate treatment among treatment and non-treatment seeking patients. This project is designed to test two clinically relevant ED-initiated treatment models for patients with alcohol use disorders (AUD) with facilitated referal and direct linkage to ongoing treatment. Our two models include currently underutilized psychosocial and pharmacological interventions with referral for continuation AUD treatment with the goal of promoting ongoing treatment engagement and less heavy drinking days.