Emergency Department treatment for Alcohol Use Disorder
Emergency Department-Initiated Medications for Alcohol Use Disorder
This study tests a new approach in the Emergency Department that combines medication and support to help people with moderate to severe alcohol use disorder reduce their drinking and stay engaged in treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05827159 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a comprehensive intervention for moderate to severe Alcohol Use Disorder (AUD) initiated in the Emergency Department (ED). It combines Screening, Brief Intervention, and Referral to Treatment (SBIRT) with medications like naltrexone and gabapentin to improve treatment engagement and reduce heavy drinking days. Participants will be screened for AUD and randomized to receive either medication treatment or standard care, with follow-up assessments conducted 30 days post-ED visit. This approach aims to enhance access to AUD treatment for individuals frequently seeking care in the ED.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 diagnosed with moderate to severe Alcohol Use Disorder who are willing to comply with study procedures.
Not a fit: Patients with current opioid use disorder or those requiring opioid pain medications during the study period may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly increase treatment participation rates for individuals with Alcohol Use Disorder.
How similar studies have performed: While this specific approach is novel, similar ED-based interventions for other conditions have shown success in improving treatment engagement.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: 1. A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl) 2. Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery) 3. History of complicated alcohol withdrawal 4. Condition that precludes interview (i.e., life threatening injury/illness) 5. Inability to consent due to cognitive impairment 6. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation 7. In police custody 8. Unable to provide contact information 9. Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention 10. Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronic conditions such as chronic obstructive pulmonary disease (COPD). 11. Creatine Clearance \<60 mL/min within past 72 hours. 12. Currently pregnant or breast feeding 13. Requiring hospitalization at the time of the index visit 14. Past week treatment with medications for the treatment of alcohol use disorder 15. Taking gabapentin or naltrexone for any reason 16. Appearing unable or unwilling to comply with discharge instructions or complete follow-up 17. Current residence outside of the state of Connecticut
Where this trial is running
New Haven, Connecticut
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn Hawk, MD, MHS — Yale University
- Study coordinator: Kathryn Hawk, MD, MHS
- Email: Kathryn.hawk@yale.edu
- Phone: 267-334-4415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.