Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Meeting ICD-10 criteria for Alcohol Dependence Syndrome (F10.2) 2.Successfully completed acute alcohol detoxification (minimum 7 days abstinent) 3.Presence of protracted withdrawal symptoms as defined by: Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) score less than 8 and Score more than or equal to 25 on the Alcohol Withdrawal Symptom Checklist (AWSC) for persistent symptoms 4.Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1.Current diagnosis of other substance use disorders (except nicotine and caffeine) 2.History of seizure disorder unrelated to alcohol withdrawal 3.Presence of serious psychiatric illness requiring immediate intervention 4.Significant medical conditions including severe hepatic or renal impairment, cardiovascular or respiratory diseases 5.Known hypersensitivity to NAC or any components of the formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Alcohol Withdrawal Symptom Checklist (AWSC) score at 8 weeks.Timepoint: Day 0, 28 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Penn Alcohol Craving Scale, Visual Analog Scale for Craving, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, Pittsburgh Sleep Quality Index, Montreal Cognitive AssessmentTimepoint: Day 0, 28 and 56 | — |
Countries
India
Contacts
Kalinga Institute of Medical Sciences, Bhubaneswar