Health Condition 1: null- Alcohol Dependence Syndrome
Conditions
Interventions
Intervention1: Topiramate: 50-300mg/day in 2 divided doses, orally for 12 weeks.
Control Intervention1: BACLOFEN: 20-40 mg/day in 3 divided doses, orally for 12 weeks.
Sponsors
Government Medical College Hospital GMCH
Eligibility
Inclusion criteria
Inclusion criteria: a)age 18-65 years b) males c) patients meeting diagnostic criteria for alcohol dependence as per ICD-10 classification
Exclusion criteria
Exclusion criteria: a) Presence of serious physical illness such as renal dysfunction, seizure disorder, cardiac disease (as assessed by thorough physical examination ,past history and routine laboratory screening) b) Presence of another current co-existing major psychiatric disorder c) Presence of another current drug abuse except nicotine and caffeine d) Patients with history of hypersensitivity reaction with these drugs in past e) Patient not willing to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Craving by Obsessive and Compulsive Drinking Scale (OCDS), Motivation by Readiness to Change Questionnaire, withdrawal symptoms by CIWA-Ar, Side effects of drugs using checklistTimepoint: At Week 1,2,3,4,6,8,10 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Craving by Obsessive and Compulsive Drinking Scale (OCDS) and Visual Analogue scale (VAS),Quality of life by WHO QOL-Bref, Field Trial Version(Hindi version),Hemogram, SERFT, LFT, side effects checklistTimepoint: baseline,week 4,8,12 | — |
Countries
India
Contacts
Public ContactB S Chavan
Govt Medical College Hospital
Outcome results
None listed