A randomized controlled trial to assess the safety and efficacy of melatonin add-on to treatment-as-usual compared to treatment-as-usual in treatment of alcohol withdrawal in individuals with alcohol dependence

Alcohol withdrawal syndrome is also characterized by severe disturbances in sleep because of reduced secretion of melatonin in the body. Exogenous administration of Melatonin has not been adequately studied for treatment of alcohol withdrawal syndrome. In the current study we want to study the efficacy of melatonin (5mg) fin controlling alcohol withdrawal syndrome. The study will be conducted as an open label trial with two arms. Participants suffering from alcohol withdrawal syndrome, meeting inclusion criteria, admitted to AIIMS Bibinagar, AIIMS Deogarh & AIIMS Guwahati Psychiatry ward, will be randomised (using block randomisation method) to either control or intervention arm. Participants in control arm will receive treatment as usual as per the standard treatment protocols for the treatment of Alcohol withdrawal syndrome. Those in Intervention arm will receive melatonin (5mg) tablet every night for 7 days along with the treatment as usual. Participants in both the arms will be assessed for various sleep indices using a wrist worn sleep tracking device for 7 days. Participants in both arms will also be assessed for severity of withdrawal symptoms every day for 7 days. The data will be compared between the two groups interms of sleep indices, withdrawal scores, benzothiazines dosage received etc.