Emergency Department-Initiated Medications for Alcohol Use Disorder
Yale University
Summary
The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD). The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive. The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.
Description
The proposed study will evaluate a comprehensive ED-based intervention for moderate to severe AUD combining SBIRT with ED-initiated MAUD. It is an extension and a novel application of a highly effective ED intervention model that has been successfully developed and broadly disseminated for other conditions, such as diabetes, hypertension and more recently opioid use disorder. No prospective randomized controlled trials of ED-initiated medications for the treatment of AUD, with or without psychosocial interventions, have been published to date. If found efficacious this novel intervention model…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Between 18 and 80 years in age 2. Diagnosed with moderate to severe Alcohol Use Disorder 3. Stated willingness and ability to comply with all study procedures and availability for the duration of the study 4. Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period 5. Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study. 6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4. Exclu…
Interventions
- DrugNaltrexone Pill
In the MAUD component, some participants will receive oral Naltrexone in the ED.
- DrugNaltrexone Injection
In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
- BehavioralBrief Negotiation Interview
Brief Negotiation Interview (BNI) has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice.
- DrugGabapentin Pill
In the MAUD component, ancillary treatment with gabapentin will be provided.
Location
- Yale New Haven HospitalNew Haven, Connecticut