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Does N-Acetylcysteine help reduce symptoms that persist after stopping alcohol use?

Efficacy of N-Acetylcysteine as Adjunctive Therapy in the Management of Protracted Alcohol Withdrawal Syndrome: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091238
Enrollment
130
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: N-Acetylcysteine: N-Acetylcysteine as oral tablets up to 2400mg/day given as an adjunct to the treatment as usual, for 8 weeks Control Intervention1: Treatment as usual: Treatment as us

Sponsors

Dr Kartik Chaudhary
Lead Sponsor

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

MeasureTime frame
Change from baseline in the Alcohol Withdrawal Symptom Checklist (AWSC) score at 8 weeks.Timepoint: Day 0, 28 and 56

Secondary

MeasureTime 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

Public ContactKartik Chaudhary

Kalinga Institute of Medical Sciences, Bhubaneswar

linksudipta@gmail.com9439728347

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026