Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Naltrexone plus Baclofen: The dosage will be 40-60 mg oral once a day for baclofen for two months and 50mg oral once a day for naltrexone for two months.
Control Intervention1: Naltrexo
Sponsors
King Georges Medical University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of alcohol dependence as per International Classification of Diseases 11th Revision (ICD-11) 2. Age between 18 and 60 years, 3. Complete abstinence for at least 10 days 4. Total Clinical Institute Withdrawal Assessment for Alcohol revised version (CIWA-Ar) score less than 8, with not more than one score on any of the items.
Exclusion criteria
Exclusion criteria: 1. A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorder 2. Current use of any psychotropic medication (except Trazodone) 3. Evidence of severe neurologic or physical disorders 4. History of cirrhosis or laboratory evidence of significant hepatocellular injury 5. Pregnancy, nursing, or refusal to use a reliable method of birth control in women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patient of alcohol dependence treated with naltrexone-baclofen combination expected to have less craving, episodes of heavy alcohol use, and relapse rate compared to the of naltrexone alone and baclofen alone.Timepoint: Baseline,2 week ,4 week ,8 week from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of participants maintaining alcohol abstinence • Total abstinence duration • Cumulative abstinence duration (as the total number of days abstinent from alcohol) • Time to Alcohol lapse • Time to Alcohol relapse • Difference in craving measures between groups • Difference in Quality of life between groups • Difference in well-being scores between groups • Adverse events attributable to medication use • Measurement of liver enzymes and biological markers of alcohol abuse (i.e. amounts of aspartate aminotransferase, alanine aminotransferase, ? glutamyl transpeptidase, and total bilirubin; and mean cellular volume)Timepoint: The patient will be reassessed at week 2, week 4, and week 8. At each scheduled visit, the strip of used medication will be collected and counted to evaluate adherence to medications. Participants self-rated craving using VAS, OCDS, and WHO well-being, WHO-QOL-Bref as a measure that characterizes the quality of life in alcohol-dependent patients, and side effects will be assessed at each scheduled visit | — |
Countries
India
Contacts
Public ContactMOHD AMAN NAQVI
King George’s Medical University
Outcome results
None listed