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NCT05827159 · ClinicalTrials.gov registry record · Phase 3
Emergency Department-Initiated Medications for Alcohol Use Disorder
A Phase 3 study of Alcohol Use Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05827159 is a Phase 3 study of Alcohol Use Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 240 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05827159, a Phase 3 study of Alcohol Use Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Naltrexone Pill
- DRUG Naltrexone Injection
- BEHAVIORAL Brief Negotiation Interview
- DRUG Gabapentin Pill
Study Locations (1)
Connecticut
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-08-17 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05827159
The ClinicalTrials.gov registry entry for NCT05827159 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (27% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 4 interventions - of which Naltrexone Pill is the first listed.
NCT05827159 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT05827159 about?
NCT05827159 is a clinical study titled "Emergency Department-Initiated Medications for Alcohol Use Disorder". 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 treatm...
What is the current status of trial NCT05827159?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2024-08-17. Estimated completion is 2028-03-01.
What conditions does trial NCT05827159 study?
This clinical trial studies the following conditions: Alcohol Use Disorder.
What interventions are being tested in trial NCT05827159?
The interventions under investigation include: Naltrexone Pill (DRUG), Naltrexone Injection (DRUG), Brief Negotiation Interview (BEHAVIORAL), Gabapentin Pill (DRUG).
Who is sponsoring clinical trial NCT05827159?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05827159 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.