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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: Recruiting Phase 3 study of Alcohol Use Disorder, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportions of participants participating in AUD treatment on day 30 post enrollment in SBIRT and SBIRT+EDMAUD groups.
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 |
What NCT05827159 shows while recruiting
NCT05827159 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (27% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05827159's enrollment target sits among peer trials
240 37th of 184 higher than 147 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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