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NCT01362205 · ClinicalTrials.gov registry record · Phase 4

Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)

A Phase 4 study, sponsored by Denver Health and Hospital Authority.

Terminated
Registry status
Phase 4
Development phase
49
Enrollment target

NCT01362205: Clinical Trial Phase 4 study, sponsored by Denver Health and Hospital Authority.

NCT01362205 is a Phase 4 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01362205, a Phase 4 study, was terminated before completion, sponsored by Denver Health and Hospital Authority.

TERMINATED
Registry status
Phase 4
Development phase
49 participants
Enrollment target

Study Summary

This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults. The investigators hypothesize that the integration of dexmedetomidine (Precedex®) with usual therapy for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium/delirium tremens (AWD) in critically ill adult patients will reduce the time to resolution of AWS/AWD, increase the number of delirium-free and ventilator-free days in the first 28 days of hospitalization, reduce the length of ICU and hospital stays, and improve neurocognitive and quality of life scores on hospital discharge.

Interventions

  • DRUG Placebos
  • DRUG Dexmedetomidine

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2012-03
Est. Completion 2016-09
Phase Phase 4

Why NCT01362205 stopped before completion

NCT01362205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.

NCT01362205 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01362205 about?

NCT01362205 is a clinical study titled "Dexmedetomidine (Precedex®) for Severe Alcohol Withdrawal Syndrome (AWS) and Alcohol Withdrawal Delirium (AWD)". This is a prospective, randomized, double-blind, placebo-controlled, parallel-group study of dexmedetomidine versus placebo, with lorazepam rescue, for the management of severe alcohol withdrawal syndrome (AWS) and alcohol withdrawal delirium (AWD) in critically ill adults. The investigators hypoth...

What is the current status of trial NCT01362205?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2012-03. Estimated completion is 2016-09.

What interventions are being tested in trial NCT01362205?

The interventions under investigation include: Placebos (DRUG), Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT01362205?

This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01362205's enrollment target sits among peer trials

49 1323rd of 2000 higher than 670 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT01362205, the US trial registry maintained by the National Library of Medicine. NCT01362205 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.