Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Tablet Naltrexone 50 mg plus
Tab Topiramate 50 mg: Along with naltrexone (50mg/day), the intervention group will receive an additional topiramate (50mg/day) tablet.The patients will be
Sponsors
King George Medical University
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of alcohol dependence as per International Classification of Diseases 11th Revision (ICD-11) Males with age between 18 and 50 years, Complete abstinence from alcohol for at least 7 days CIWA-Ar score less than 5 Not on any benzodiazepines for at least 3 days Written informed consent from patient
Exclusion criteria
Exclusion criteria: A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorder Current use of any psychotropic medication (except Trazodone up to 100mg for sleep disturbance) Evidence of severe neurologic or physical disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare reduction in craving in patients of alcohol dependence treated with naltrexone-topiramate combination as compared to those treated with naltrexone aloneTimepoint: Baseline 2 weeks 4 weeks 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare reduction in episodes of heavy alcohol use and relapse rate in patients of alcohol dependence treated with naltrexone-topiramate combination as compared to those treated with naltrexone aloneTimepoint: Baseline 2 weeks 4 weeks 6 weeks | — |
Countries
India
Contacts
Public ContactDr Ayush Maheshwari
King george medical university
Outcome results
None listed