Emergency Department-Initiated Medications for Alcohol Use Disorder

April 22, 2024 updated by: Kathryn Hawk, Yale University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Other Names:
  • BNI
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 30-day take-home doses of naltrexone and 7 days of gabapentin.
Behavioral: 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.
Other Names:
  • BNI
Drug: Naltrexone Pill
In the MAUD component, some participants will receive oral Naltrexone in the ED.
Other Names:
  • Oral naltrexone
Drug: Naltrexone Injection
In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
Other Names:
  • XR-NTX
Drug: Gabapentin Pill
In the MAUD component, ancillary treatment with gabapentin will be provided.
Other Names:
  • Oral gabapentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation in AUD Treatment on Day 30 post-randomization
Time Frame: 30 days post enrollment
The proportions of participants participating in AUD treatment on day 30 post enrollment in SBIRT and SBIRT+EDMAUD groups.
30 days post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of heavy alcohol drinking
Time Frame: 30 days post ED visit
The number of heavy alcohol drinking days during the 30 days prior and during 30 days post the ED index visit. This outcome will be based on self-report using the timeline follow-back (TLFB) method. A day of heavy alcohol drinking is defined by the NIAAA criteria as: for men, consuming more than 4 drinks on any day; for women, consuming more than 3 drinks on any day.
30 days post ED visit
AUD Treatment Linkage
Time Frame: up to 7 days post ED visit
The proportion of participants that initiate AUD treatment within 7 days post ED visit with providers to which they were referred during the ED visit
up to 7 days post ED visit
Alcohol craving
Time Frame: up to 7 days post enrollment
Daily intensity of alcohol craving measured on a visual analog scale of 0 to 100.
up to 7 days post enrollment
Alcohol withdrawal symptoms
Time Frame: up to 7 days post enrollment
Daily intensity of alcohol withdrawal measured on a visual analog scale of 0 to 100.
up to 7 days post enrollment
Daily naltrexone medication adherence
Time Frame: up to 7 days post enrollment
Number of oral naltrexone doses taken in the past 24 hours for 7 days post enrollment of those initiated on oral naltrexone in the SBIRT+ED- MAUD arm.
up to 7 days post enrollment
Daily gabapentin medication adherence
Time Frame: up to 7 days post enrollment
Number of gabapentin doses taken in the past 24 hours of those in the SBIRT+ED- MAUD arm.
up to 7 days post enrollment
Treatment linkage
Time Frame: 7 days
• Proportion of patients in each of the two study arms initiating outpatient AUD treatment within 7 days post the ED visit with providers to which they were referred during the ED visit.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Kathryn Hawk, MD, MHS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000034359
  • 1R01AA030568-01 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available through NIAAA Data Archive

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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