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ED-Initiated Naltrexone + Gabapentin for Alcoholism

Phase 3

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participation in AUD Treatment on Day 30 post-randomization

Secondary outcome measures

AUD Treatment Linkage

Alcohol craving

Alcohol withdrawal symptoms

+4 more

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 30-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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,737,428 Total Patients Enrolled

83 Trials studying Alcoholism

9,989 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,271 Total Patients Enrolled

422 Trials studying Alcoholism

984,968 Patients Enrolled for Alcoholism

Kathryn Hawk, MD, MHSPrincipal InvestigatorYale University

Media Library

Brief Negotiation Interview Clinical Trial Eligibility Overview. Trial Name: NCT05827159 — Phase 3

Alcoholism Research Study Groups: SBIRT, SBIRT+ED-MAUD

Alcoholism Clinical Trial 2023: Brief Negotiation Interview Highlights & Side Effects. Trial Name: NCT05827159 — Phase 3

Brief Negotiation Interview 2023 Treatment Timeline for Medical Study. Trial Name: NCT05827159 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals within the 55 year age boundary eligible to participate in this investigation?

"This clinical trial is only open to those who are of legal age or older, but no more than 80 years old."

Answered by AI

Do I meet the criteria to be included in this medical research?

"To be eligible for this medical trial, individuals must have a diagnosis of alcoholism and fall between the ages of 18-80. This research project has space for up to 240 participants in total."

Answered by AI

Have any government entities sanctioned the use of SBIRT?

"Based on our evaluation, SBIRT has been given a score of 3 due to the evidence-based efficacy and extensive safety data."

Answered by AI

Is there still an opportunity to join this experiment?

"The clinicaltrials.gov website displays that this particular trial, which debuted on July 1st 2023 and last edited April 12th 2023, is not currently seeking candidates for enrollment. However, there are 581 other medical studies open to enlistment at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Emergency Department-Initiated Medications for Alcohol Use Disorder

Kathryn Hawk 2024. "Emergency Department-Initiated Medications for Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05827159.

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