Baclofen in Managing Acute Alcohol Withdrawal

Status Recruiting

Clinical Trial Summary

The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.

Clinical Trial Description

The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03293017
Study type	Interventional
Source	Universitair Ziekenhuis Brussel
Contact	Cleo L Crunelle, PhD
Email	nacstudie@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	February 1, 2016
Completion date	February 1, 2022

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