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NCT00597701 · ClinicalTrials.gov registry record · NA

Treating Alcohol Withdrawal With Oral Baclofen

A NA study, sponsored by Essentia Health.

Completed
Registry status
NA
Development phase
79
Enrollment target

NCT00597701: Completed NA study, sponsored by Essentia Health.

NCT00597701 is a NA study that has completed, run by Essentia Health. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00597701, a NA study, has completed, sponsored by Essentia Health.

COMPLETED
Registry status
NA
Development phase
79 participants
Enrollment target

Study Summary

The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AWS)who receive baclofen plus standard benzodiazepine therapy will experience fewer complications of AWS (as measured by use of additional sedatives, restraints, and/or intensive care unit \[ICU\] admissions) compared with subjects who receive placebo plus standard benzodiazepine therapy.

Primary Outcome

In acutely-withdrawing alcoholic patients treated with either baclofen or placebo, symptom-driven benzodiazepine doses were assessed for the 72 hours following the first Clinical Institute Withdrawal Assessment (CIWA) score of 11 or greater.

Interventions

  • DRUG Placebo
  • DRUG Lorazepam
  • DRUG Baclofen

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2003-04
Est. Completion 2008-02
Phase NA
Essentia Health

17 total trials

What the finished NCT00597701 record still lists

NCT00597701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00597701 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00597701 about?

NCT00597701 is a clinical study titled "Treating Alcohol Withdrawal With Oral Baclofen". The purpose of this study is determine if subjects with alcohol withdrawal who receive oral baclofen, plus standard benzodiazepine therapy, will experience less severe withdrawal symptoms than those who receive placebo plus standard benzodiazepine therapy.Subjects with alcohol withdrawal syndrome(AW...

What is the current status of trial NCT00597701?

This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2003-04. Estimated completion is 2008-02.

What interventions are being tested in trial NCT00597701?

The interventions under investigation include: Placebo (DRUG), Lorazepam (DRUG), Baclofen (DRUG).

Who is sponsoring clinical trial NCT00597701?

This trial is sponsored by Essentia Health, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00597701's enrollment target sits among peer trials

79 1060th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00597701, the US trial registry maintained by the National Library of Medicine. NCT00597701 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.