Baclofen in managing acute alcohol withdrawal

Phase 1

Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Alcohol withdrawal syndrome

Registration Number: EUCTR2015-005286-24-BE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Be an inpatient at unit A220 (UZ Brussel) at time of study enrolment.

• Be able to sign informed consent.

• Be male/female aged 18-60

• Primary diagnosis of alcohol use disorder.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnancy and breastfeeding.

• Benzodiazepine use of more than the equivalent of lorazepam 5 mg /day.
(to assess this we will adopt the table included in annex 1)

• Psychosis, confusion and acute mania.

• Parkinson’s disease.

• Use of tricyclic antidrepressants.

• Use of opioids.

• Known baclofen or benzodiazepine sensitivity or allergy.

• Unable to take oral meds.

• EGFR < 60 (blood samples are routinely performed at intake).

• Prior diagnosis of epilepsy.

• Lactose intolerance.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Our goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal.<br>We will do this by comparing placebo and doses of baclofen 30 and 60 mg/day in patients receiving symptom triggered diazepam.<br>;Secondary Objective: Not applicable;Primary end point(s): 7 days after administration of first dose of placebo or baclofen;Timepoint(s) of evaluation of this end point: after the seven days of the study

Secondary Outcome Measures