Status:
UNKNOWN
Baclofen in Managing Acute Alcohol Withdrawal
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Alcohol Use Disorder
Alcohol Withdrawal
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 d...
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 - baclofe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03293017
Start Date
February 1 2016
End Date
February 1 2022
Last Update
November 4 2021
Active Locations (1)
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1
University Hospital Brussels
Brussels, Belgium, 1090