MedTrace Logo

Baclofen in Managing Acute Alcohol Withdrawal

NCT03293017 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-04

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

Baclofen 60mg

Baclofen 60 mg/day given over three gifts daily

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Frieda Matthys, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293017 on ClinicalTrials.gov