Health Condition 1: F102- Alcohol dependence Health Condition 2: F102- Alcohol dependence
Conditions
Interventions
Intervention1: TAb Lemborexant: 10 mg will be given for 7 days
Control Intervention1: Placebo: Placebo will be given for 7 days
Sponsors
Dr Dharuvika
Eligibility
Inclusion criteria
Inclusion criteria: The inclusion criteria would be patients aged between 18-65 years, diagnosed with alcohol induced delirium according to ICD-11 and whose caregivers will provide written informed consent
Exclusion criteria
Exclusion criteria: The exclusion criteria will be presence of Wernicke-Korsakoff syndrome, Child-Pugh Class 3 class of liver disease, hepatic encephalopathy, delirium due to disease classified elsewhere, uncontrolled medical illness requiring urgent management, comatose condition, previous neurological insult, previous psychiatric illness,comorbid dementia, inability to take oral drugs, delirium due to another substance use disorder including medications and known allergy to any of the study medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure of this study will be the days taken for resolution of delirium between the two groups i.e treatment as usual (benzodiazepines) versus treatment as usual + Lemborexant group (10mg).Timepoint: Baseline, Day 2, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures of this study will be change in CIWA-Ar scores and MDAS scores from baseline to Day 2 and Day 7 between the two groups. Other outcome measures will be the total dose (in mg) of lorazepam required and number and dose of rescue medications requiredTimepoint: Baseline, Day 2, Day 7 | — |
Countries
India
Contacts
Public ContactDr Dharuvika
Himalayan Institute of Medical Sciences , Swami Rama Himalayan University, Jollygant , Dehradun
Outcome results
None listed