To study the efficacy and safety of Baclofen versus Baclofen and Naltrexone as Anticraving agents in patients of Alcohol Dependence with Alcoholic Liver Disease

Alcohol dependence (AD) is a global health problem. There are several pathways involved in the development and maintenance of alcohol dependence including dopaminergic, glutamergic and GABAergic pathways. Treatment of AD consists of two phases: detoxification and rehabilitation. Anticraving medications for Alcohol Use Disorder (AUD) include, naltrexone, acamprosate, baclofen. The role of anticraving agents in AD with alcoholic liver disease has been studied less. Therefore, the current study is taken to explore the efficacy and safety of baclofen versus baclofen and naltrexone combination in patients of AD with alcoholic liver disease. It will be a hospital based, interventional, comparative and prospective follow-up, single-blind randomized trial. Screening for AD will be done using AUDIT scale. A total of 150 patients of AD with Alcoholic Liver Disease (ALD) diagnosed as per DSM-5 tr and ACG guidelines, respectively. The socio-demographic and clinical data will be recorded. Participants will be assigned into three groups by simple random sampling comprising of 50 patients each. Group A (Baclofen), Group B (Baclofen and Naltrexone) combination and placebo (Control) group. Primary outcome will include efficacy assessment by TLBF scale, OCDS, VASC, CIWA-Ar and safety assessment by serial LFTs. Secondary outcome will be assessed by prognostic scoring on Maddrey Discriminant function (MDf). The observations will be done at the time of admission and follow-ups after 1 month, 2 months, 3 months and 6 months, respectively. Data will be analysed by the relevant tests wherever applicable at statistically significant p value ≤ 0.05.