Baclofen in Managing Acute Alcohol Withdrawal

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Treatments: Baclofen; Diazepam

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:

• 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.