Emergency Department-Initiated Medications for Alcohol Use Disorder

Last updated: May 15, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

3

Condition

Alcohol Use Disorder

Addictions

Alcohol Dependence

Treatment

Brief Negotiation Interview

Naltrexone Pill

Gabapentin Pill

Clinical Study ID

NCT05827159
2000034359
1R01AA030568-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 availabilityfor the duration of the study

  4. Reproductive aged females will have a negative pregnancy test within the past 24hours and agree to use of highly effective family planning during studyparticipation period

  5. Able to speak English sufficiently to understand study procedures and providewritten informed consent to participate in the study.

  6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.

Exclusion

Exclusion Criteria:

  1. A current diagnosis of OUD, self-reported past 7 day opioid or opioid painmedication 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 painmedications 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 whichthey are currently receiving study medications or active ongoing intervention

  10. Any contraindication to naltrexone or gabapentin, including known allergy, renalfailure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronicconditions 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 completefollow-up

  17. Current residence outside of the state of Connecticut

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Brief Negotiation Interview
Phase: 3
Study Start date:
August 17, 2024
Estimated Completion Date:
March 01, 2028

Study 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 has a potential to increase AUD treatment participation rates among individuals with AUD who frequently receive care in the ED. The proposed study will evaluate two ED-based interventions that have a potential to be broadly disseminated to narrow the gap between treatment need and treatment access.

Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized. This study will compare outcomes among individuals who are initiated on MAUD treatment in the ED, including AUD treatment with naltrexone, with ancillary support of gabapentin to assist with withdrawal symptoms.

Hypothesis 1: The rates of AUD treatment engagement will be higher among patients receiving SBIRT+ED-MAUD.

Hypothesis 2: Those randomized to SBIRT+ED-MAUD will have greater reductions of heavy drinking days.

This study is not designed to change the FDA labeling of gabapentin.

Connect with a study center

  • Yale New Haven Hospital

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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