Emergency Department-Initiated Medications for Alcohol Use Disorder

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05827159
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Naltrexone Pill — DRUG
    In the MAUD component, some participants will receive oral Naltrexone in the ED.
  • Naltrexone Injection — DRUG
    In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
  • 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.
  • Gabapentin Pill — DRUG
    In the MAUD component, ancillary treatment with gabapentin will be provided.

Study Details

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.

Key Dates

Start date
Aug 17, 2024
Status verified
May 2025
Primary completion
Dec 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06520
Kathryn Hawk, MD, MHS
[email protected]
203-688-2222
Kathryn Hawk, MD, MHS (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Yale New Haven Hospital· New Haven, CT

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