Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Cannabidiol syrup: Patients who are allotted to study group will be given oral cannabidiol upto a maximum of 300mg in divided doses, on the first day they will be started with 75mg BD a
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Patients hospitalized for alcohol dependence as per ICD-11 criteria
Exclusion criteria
Exclusion criteria: Any unstable medical condition at entry, such as acute confusion, chronic or acute hepatic or renal impairment or cirrhosis or any acute psychiatric disorder Elevated liver enzymes (more than 3 times) and or or elevated bilirubin Previously using or need medication which metabolise through CYP 2C19 or CYP3A4 or UGT enzymes and having strong inhibitor or inducer properties Concomitant use of other medications, including leflunomide, lomitapide, mipomersen, pexidartinib, teriflunomide, and valproate, is known to cause liver damage Those with history of cardiac arrhythmias, myocardial infarction and stroke Other current substance dependence as per ICD 11 criteria (like opiates, cannabis, cocaine, amphetamines, sedatives) except for tobacco use disorder Pregnancy and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of withdrawal symptomsTimepoint: Day 1 of admission to week 6 (daily till day 10, then day 14, day 21, 28, 35, 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospital stayTimepoint: Till week 6 of the study;Reduction in cravingTimepoint: Day 1 of admission to week 6 (daily till day 10, then day 14, day 21, 28, 35, 42);Alcohol consumption patternTimepoint: From discharge - day 21, 28, 35, 42;Safety of cannabidiolTimepoint: Baseline, day 7, day 14, 21, 28, 35;Cumulative dose of benzodiazepine neededTimepoint: from day 1 to day 10 of admission | — |
Countries
India
Contacts
Public ContactDr Mamidipalli Sai Spoorthy
All India Institute of Medical sciences, Bibinagar
Outcome results
None listed