NCT03293017

Baclofen in Managing Acute Alcohol Withdrawal

Baclofen Bij de Behandeling Van Acute Alcoholontwenning

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alcohol Use Disorder
• Alcohol Withdrawal

Interventions

Type	Name	Description
DRUG	Diazepam 10 MG	If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.
DRUG	Baclofen 30mg	Baclofen 30 mg/day given over three gifts daily
DRUG	Baclofen 60mg	Baclofen 60 mg/day given over three gifts daily

Timeline

• Start date: 2016-02-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2017-09-26
• Last updated: 2021-11-04

Locations

1 site across 1 country: Belgium