Prospective, multi-center, open-label study to evaluate the effectiveness and safety of chlordiazepoxide in mild to moderate Alcohol withdrawal syndrome patients using CIWA-Ar scale in Deaddiction centers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Abbott Healthcare Pvt Ltd
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Percentage reduction in AWS symptoms based on daily CIWA Ar
Study Overview
Brief Summary
Alcohol abuse is the biggest problem here: India has an estimated 160 million users of alcohol. This adds up to 14.6% of the Indian population. About 5.2% of the Indian population needs treatment for alcohol dependence. Alcohol withdrawal syndrome (AWS) occurs when patients stop drinking or significantly decrease their alcohol intake after long-term dependence. The clinical presentation varies from mild to severe, and the onset of symptoms typically occurs a few hours after the last alcohol intake. Benzodiazepines have the largest and the best evidence base in the treatment of alcohol withdrawal. Long-acting BZD are preferred and are considered as the gold standard. Chlordiazepoxide is a long-acting benzodiazepine, that is used in patients with AWS. The starting dose of Chlordiazepoxide in AWS patients usually ranges from 100-150mg/day, which is subsequently down-titrated over a period of 10-15 days and gradually withdrawn. Currently, there are limited Indian studies on safety and effectiveness of chlordiazepoxide in AWS patients.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Males and females of more than 18 to less than 60 years Patients should be admitted in deaddiction centers after 6 hours of last alcohol use with Day 0 CIWA Ar score Patients meet criteria for mild to moderate AWS (DSM V) by the investigator Patient admitted in the deaddiction centers should be willing to give consent to participate into the trial Liver Parameters- AST or ALT less than 2 times ULN.
Exclusion Criteria
- •Dependent on any substance other than alcohol except nicotine History of severe alcohol withdrawal complications (alcohol withdrawal seizures, epilepsy or delirium tremens) History of hepatic encephalopathy less than 1 year & other liver disease less than 6 months Received medications that may alter AWS presentation such as Antipsychotics other benzodiazepines (except rescue doses)) Known contraindications to chlordiazepoxide Pregnant or nursing females Patients with the inability or unwillingness to comply with the study protocol.
Outcomes
Primary Outcomes
Percentage reduction in AWS symptoms based on daily CIWA Ar
Time Frame: Day 0 baseline to day 12
score from baseline to day 12
Time Frame: Day 0 baseline to day 12
Secondary Outcomes
- LFT parameter before and at end of the study period(Number of days required for reduction of agitation and tremors)