Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2016-02-01
2022-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baclofen 30 mg/day
baclofen 30 mg/day
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 60 mg/day
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 60mg
Baclofen 60 mg/day given over three gifts daily
Placebo
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Be able to sign informed consent.
* Be male/female aged 18-60
* Primary diagnosis of alcohol use disorder.
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Frieda Matthys, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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University Hospital Brussels
Brussels, , Belgium
Countries
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Central Contacts
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Sami Jegham, MD
Role: CONTACT
Facility Contacts
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Cleo L Crunelle, PhD
Role: primary
Other Identifiers
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22112015
Identifier Type: -
Identifier Source: org_study_id