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ED-Initiated Naltrexone + Gabapentin for Alcoholism

Phase 3

Recruiting

Led By Kathryn Hawk, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post ed visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will evaluate if an ED-based intervention combining screening, brief intervention, and referral to treatment plus ED-initiated medications for AUD can reduce drinking days and improve treatment engagement.

Who is the study for?

This trial is for adults aged 18-80 with moderate to severe Alcohol Use Disorder not in remission. Participants must be willing and able to follow the study procedures, available for its duration, and speak English well enough to understand it. Women of childbearing age must test negative for pregnancy and agree to effective birth control during the study.

What is being tested?

The trial tests if starting medications (Naltrexone Pill or Injection, Gabapentin Pill) in the emergency department helps people with alcohol use disorder engage better in treatment after 30 days compared to just a brief intervention and referral. It's a phase 3 study where participants are randomly assigned treatments.

What are the potential side effects?

Possible side effects include nausea, headache, dizziness from Naltrexone; sleepiness or seizures from Gabapentin. The severity can vary among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post ed visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post ed visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post ed visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participation in AUD Treatment on Day 30 post-randomization

Secondary study objectives

AUD Treatment Linkage

Alcohol craving

Alcohol withdrawal symptoms

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SBIRT+ED-MAUDExperimental Treatment4 Interventions

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.

Group II: SBIRTExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naltrexone Pill

2021

Completed Phase 4

~220

Naltrexone Injection

2017

N/A

~190