Emergency Department-Initiated Medications for Alcohol Use Disorder

NCT05827159 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 20000343591R01AA030568-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Emergency Department; Brief Intervention; Naltrexone; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Participation in AUD Treatment on Day 30 post-randomization

  The proportions of participants participating in AUD treatment on day 30 post enrollment in SBIRT and SBIRT+EDMAUD groups.

  30 days post enrollment

Secondary Outcomes (7)

• Days of heavy alcohol drinking

  30 days post ED visit

• AUD Treatment Linkage

  up to 7 days post ED visit

• Alcohol craving

  up to 7 days post enrollment

• Alcohol withdrawal symptoms

  up to 7 days post enrollment

• Daily naltrexone medication adherence

  up to 7 days post enrollment

Study Arms (2)

SBIRT

EXPERIMENTAL

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

SBIRT+ED-MAUD

EXPERIMENTAL

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.

Drug: Naltrexone Pill; Drug: Naltrexone Injection; Behavioral: Brief Negotiation Interview; Drug: Gabapentin Pill

Interventions

Naltrexone Pill DRUG

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

Also known as: Oral naltrexone

SBIRT+ED-MAUD

Naltrexone Injection DRUG

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

Also known as: XR-NTX

SBIRT+ED-MAUD

Brief Negotiation Interview BEHAVIORAL

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.

Also known as: BNI

SBIRT; SBIRT+ED-MAUD

Gabapentin Pill DRUG

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

Also known as: Oral gabapentin

SBIRT+ED-MAUD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 80 years in age
• Diagnosed with moderate to severe Alcohol Use Disorder
• Stated willingness and ability to comply with all study procedures and availability for the duration of the study
• 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
• Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
• Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.

You may not qualify if:

• 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)
• Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
• History of complicated alcohol withdrawal
• Condition that precludes interview (i.e., life threatening injury/illness)
• Inability to consent due to cognitive impairment
• Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
• In police custody
• Unable to provide contact information
• Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention
• 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).
• Creatine Clearance \<60 mL/min within past 72 hours.
• Currently pregnant or breast feeding
• Requiring hospitalization at the time of the index visit
• Past week treatment with medications for the treatment of alcohol use disorder
• Taking gabapentin or naltrexone for any reason

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Emergencies

Interventions

Naltrexone; Gabapentin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kathryn Hawk, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Hawk, MD, MHS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine and Epidemiology (Chronic Disease)

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: August 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)