Alcohol Use Disorder, Alcohol Withdrawal
Conditions
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.
Interventions
DRUGDiazepam 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.
DRUGBaclofen 30mg
Baclofen 30 mg/day given over three gifts daily
DRUGBaclofen 60mg
Baclofen 60 mg/day given over three gifts daily
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactCleo L Crunelle, PhD
Backup ContactSami Jegham, MD
Outcome results
None listed