Actively Recruiting
Emergency Department-Initiated Medications for Alcohol Use Disorder
Led by Yale University · Updated on 2025-05-18
240
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Emergency Department-Initiated Medications for Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 80 years in age
- Diagnosed with moderate to severe Alcohol Use Disorder
- Willing and able to comply with all study procedures and be available for the study duration
- Reproductive-aged females must have a negative pregnancy test within 24 hours and agree to use effective contraception during the study
- Able to speak English well enough to understand the study and provide written informed consent
- Clinical Alcohol Withdrawal Scale (CIWA-Ar) score of 4 or higher
You will not qualify if you...
- Current diagnosis of opioid use disorder or opioid use in the past 7 days, or positive opioid urine screen
- Current or planned use of opioid pain medications during the study period
- History of complicated alcohol withdrawal
- Conditions preventing interview (e.g., life-threatening injury or illness)
- Cognitive impairment preventing consent
- Awaiting acute psychiatric evaluation for psychosis or suicidal thoughts
- In police custody
- Unable to provide contact information
- Previously or currently enrolled in studies involving study medications or active interventions
- Contraindications to naltrexone or gabapentin, including allergies, renal failure, acute hepatitis, hepatic failure, severe lung disease, or other chronic conditions like COPD
- Creatinine clearance less than 60 mL/min within past 72 hours
- Currently pregnant or breastfeeding
- Requiring hospitalization at the index ED visit
- Treatment with AUD medications in the past week
- Currently taking gabapentin or naltrexone for any reason
- Unable or unwilling to follow discharge instructions or complete follow-up
- Living outside the state of Connecticut
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
K
Kathryn Hawk, MD, MHS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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