Baclofen in Managing Acute Alcohol Withdrawal

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Alcohol Withdrawal; Alcohol Use Disorder

Treatments: Drug: Diazepam 10 MG; Drug: Baclofen 60mg; Drug: Baclofen 30mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03293017

22112015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Baclofen 30 mg/day

Experimental group

Description:

baclofen 30 mg/day

Treatment:

Drug: Baclofen 30mg

Drug: Diazepam 10 MG

Baclofen 60 mg/day

Experimental group

Treatment:

Drug: Baclofen 60mg

Drug: Diazepam 10 MG

Placebo

Placebo Comparator group

Treatment:

Drug: Diazepam 10 MG