Recruiting
Phase 3

Alcohol Use Disorder

Sponsor:

Yale University

Code:

NCT05827159

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Naltrexone Pill

Naltrexone Injection

Brief Negotiation Interview

Gabapentin Pill

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Study ID

NCT05827159

Start date

Aug 17, 2024

Status verified date

Jul, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBIRT

Participants will receive the Brief Negotiation Interview (BNI) and Referral to Treatment. The 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.

experimental: SBIRT+ED-MAUD

Participants with receive BNI, Referral to Treatment, and MAUD. In the MAUD component, either XR-NTX or oral naltrexone will be provided, supplemented by ancillary treatment with gabapentin. Participants will receive their first doses of XR-NTX (injection) and gabapentin in the ED and will receive 7 days of gabapentin take-home doses. Those who prefer to initiate treatment in ED with oral naltrexone receive their first doses of naltrexone and gabapentin in the ED and receive 29-day take-home doses of naltrexone and 7 days of gabapentin.

Interventions

Naltrexone Pill

In the MAUD component, some participants will receive oral Naltrexone in the ED.

Naltrexone Injection

In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.

Brief 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.

Gabapentin Pill

In the MAUD component, ancillary treatment with gabapentin will be provided.

Primary outcome measure

  • Participation in AUD Treatment on Day 30 post-randomization [ Time Frame: 30 days post enrollment ]

Central Contacts and Locations

Central contacts

Kathryn Hawk, MD, MHS

267-334-4415Kathryn.hawk@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Kathryn Hawk, MD, MHS

203-688-2222kathryn.hawk@yale.edu

Principal Investigator:

Kathryn Hawk, MD, MHS

More Information

Sponsor

Yale University

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Emergency Department
  • Brief Intervention
  • Naltrexone
  • Gabapentin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-07-21.