Study of effects of Naltrexone treatment in alcohol dependent patients and influence by genotypes.Naltrexone is an FDA approved medication for treating alcohol dependence
- Conditions
- Health Condition 1: null- Alcohol Dependence Syndrome
- Registration Number
- CTRI/2017/12/010848
- Lead Sponsor
- avina Suresh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.ICD 10 criteria for alcohol use disorder.
2.Alcohol use disorder male subjects between the age group 18 to 60 years.
3.Abstinence from alcohol and other substances for 3-7 days.
4.Ability to provide informed consent.
5. One or more relatives or significant others who are willing to encourage medication therapy, adherence and provide follow-up information if contacted by research staff.
1.Major psychiatric disorder (i.e, schizophrenia, bipolar disorder, seizure disorder, alcohol induced psychotic disorder or dementia).
2.Advanced neurological, cardiovascular, renal, or hepatic disease; active tuberculosis or current febrile illness.
3.AIDS defining illness.
4.Significant laboratory abnormality (alanine aminotransferase/aspartate aminotransferase [ALT/AST] levels of greater than 5 times the top reference limit).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the occurrence of relapse, that is, presence of heavy drinking on a single day as defined by 5 or more standard drinks during any given week of the trial measured by Time-Line Follow-Back(TLFB)Timepoint: Every 2 weeks till the end of 12 weeks
- Secondary Outcome Measures
Name Time Method Other outcome measures will be the time taken to relapse, number of heavy drinking days (as defined by more than 5 drinks/day for males), number of drinks per heavy drinking day as measured by the Time-Line Follow Back method and Obsessive Compulsive Drinking Scale measure, craving measured by obsessive compulsive drinking scaleTimepoint: At end of 12 weeks