Comparing the efficacy and safety of Baclofen and Chlordiazepoxide in Alcohol Withdrawal Syndrome.

Phase 3

Completed

• Conditions: Alcohol Withdrawal Syndrome

• Registration Number: CTRI/2013/04/003588
• Lead Sponsor: Dr VIKRAM REDDY K

Brief Summary

This is a open label, randomized, controlled, two arm clinical trial to compare the efficacy and tolerability of baclofen and chlordiazepoxide in alcohol withdrawal syndrome, Baclofen 10 mg will be administered in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days and Chlordiazepoxide at a dose of 25mg in the schedule (1-1-1) up to 3 days, (1-0-1) up to 3 days and (0-0-1) up to 3 days. The efficacy of study drugs will be assessed everyday using CIWA-Ar scale and adverse effects will be recorded. Lorazepam/Haloperidol (IM) will be used as rescue medication.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-30
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects with alcohol dependence according to DSM-IV (TR) criteria.
• Last alcohol intake within 24 hour preceding the initiation of study.
• Willingness to give written informed consent.

Exclusion Criteria

• Patients with known psychiatric disorders.
• Patients with known renal and cardiovascular diseases.
• Patients with known allergy to study medications.
• Patients with multi-drug abuse.
• Patients with any other substance dependence except nicotine.
• Patients with delirium tremens.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of baclofen with chlordiazepoxide in AWS as assessed by Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar score).	10 days
Primary Outcome: lowering in CIWA-Ar severity scores.	10 days

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression(CGI) Scales.	1.Decrease in CGI-severity scale.

Trial Locations

Locations (1)

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE (KIMS) HOSPITAL, BANGALORE; 🇮🇳 Bangalore, KARNATAKA, India

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCE (KIMS) HOSPITAL, BANGALORE

🇮🇳Bangalore, KARNATAKA, India

Dr VIKRAM REDDYK

Principal investigator

8951234632

vikramred777@gmail.com