Emergency Department-Initiated Medications for Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Gabapentin; Naltrexone

Criteria

Inclusion Criteria:

1. Between 18 and 80 years in age

2. Diagnosed with moderate to severe Alcohol Use Disorder, not in remission.

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.

Exclusion Criteria:

1. A current diagnosis of OUD, self-reported recent opioid use, or a positive urine opioid screen (morphine, methadone, buprenorphine, oxycodone, hydrocodone, and fentanyl)

2. History of complicated alcohol withdrawal

3. Condition that precludes interview (i.e., life threatening injury/illness)

4. Inability to consent due to cognitive impairment

5. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation

6. In police custody

7. Unable to provide contact information

8. Previously enrolled in this study

9. Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure, or severe lung disease or other chronic conditions such as chronic obstructive pulmonary disease (COPD).

10. Creatine Clearance <60 mL/min within past 72 hours

11. Currently pregnant or breast feeding

12. Requiring hospitalization at the time of the index visit

13. Past week treatment with medications for the treatment of alcohol use disorder

14. Appearing unable or unwilling to comply with discharge instructions or complete follow-up

15. Current residence outside of the state of Connecticut