Baclofen in Managing Acute Alcohol Withdrawal

Alcohol Use Disorder Clinical Trial

Official title:

Baclofen Bij de Behandeling Van Acute Alcoholontwenning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03293017
• Other study ID #: 22112015
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2016
• Est. completion date: February 1, 2022

Study information

• Verified date: November 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: Cleo L Crunelle, PhD
• Email: nacstudie[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcohol Withdrawal
• Alcoholism

Intervention

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.
• Baclofen 30mg
Baclofen 30 mg/day given over three gifts daily
• Baclofen 60mg
Baclofen 60 mg/day given over three gifts daily

Locations

Country	Name	City	State
Belgium	University Hospital Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for additional diazepam	Amount of patients who lack the need of additional diazepam during 7-day alcohol withdrawal	Measured 7 days after the start of alcohol withdrawal
Secondary	Dosage of additional diazepam needed	The difference between the total dosages of additional diazepam needed between the three study arms	Measured 7 days after the start of alcohol withdrawal