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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
Baclofen 30 mg/day given over three gifts daily
Baclofen 60 mg/day given over three gifts daily
University Hospital Brussels
Brussels, Belgium
RECRUITINGNeed for additional diazepam
Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal
Time frame: Measured 7 days after the start of alcohol withdrawal
Dosage of additional diazepam needed
The difference between the total dosages of additional diazepam needed between the three study arms
Time frame: Measured 7 days after the start of alcohol withdrawal
Sami Jegham, MD
CONTACT
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