Baclofen in Managing Acute Alcohol Withdrawal
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Baclofen 30 mg/day baclofen 30 mg/day |
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.
Drug: Baclofen 30mg
Baclofen 30 mg/day given over three gifts daily
|
| Experimental: Baclofen 60 mg/day
|
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.
Drug: Baclofen 60mg
Baclofen 60 mg/day given over three gifts daily
|
| Placebo Comparator: Placebo
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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:
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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.
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Use of opioids.
-
Known baclofen or benzodiazepine sensitivity or allergy.
-
Unable to take oral medication.
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epidermal growth factor receptor (EGFR) < 60 (blood samples are routinely performed at intake).
-
Prior diagnosis of epilepsy.
-
Lactose intolerance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Brussels | Brussels | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Frieda Matthys, PhD, Universitair Ziekenhuis Brussel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22112015