Baclofen in Managing Acute Alcohol Withdrawal

Phase 4

• Conditions: Alcohol Use Disorder; Alcohol Withdrawal
• Interventions: Drug: Diazepam 10 MG; Drug: Baclofen 30mg; Drug: Baclofen 60mg

• Registration Number: NCT03293017
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-26
• Status Verified: 2020-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
• Be able to sign informed consent.
• Be male/female aged 18-60
• Primary diagnosis of alcohol use disorder.

Exclusion Criteria

• Pregnancy and breastfeeding.
• Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
• Psychosis, confusion and acute mania.
• Parkinson's disease.
• Use of tricyclic antidepressants.
• Use of opioids.
• Known baclofen or benzodiazepine sensitivity or allergy.
• Unable to take oral medication.
• epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake).
• Prior diagnosis of epilepsy.
• Lactose intolerance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baclofen 60 mg/day	Diazepam 10 MG	-
Baclofen 30 mg/day	Diazepam 10 MG	baclofen 30 mg/day
Placebo	Diazepam 10 MG	-
Baclofen 30 mg/day	Baclofen 30mg	baclofen 30 mg/day
Baclofen 60 mg/day	Baclofen 60mg	-

Primary Outcome Measures

Name	Time	Method
Need for additional diazepam	Measured 7 days after the start of alcohol withdrawal	Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal

Secondary Outcome Measures

Name	Time	Method
Dosage of additional diazepam needed	Measured 7 days after the start of alcohol withdrawal	The difference between the total dosages of additional diazepam needed between the three study arms

Trial Locations

Locations (1)

University Hospital Brussels; 🇧🇪 Brussels, Belgium