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

N-Acetylcysteine (NAC) as an adjunctive treatment for protracted alcohol withdrawal syndrome (PAWS).

Background

• Alcohol use disorder affects 5.4% of Indian adults
• PAWS involves persistent symptoms (anxiety, depression, sleep issues, cognitive problems, cravings) lasting weeks to months after alcohol cessation
• NAC may help through its antioxidant properties, glutamate modulation, anti-inflammatory effects, and craving regulation

Study DesignRandomized controlled trial comparing:

• Treatment group: Standard care + NAC (2400 mg daily for 8 weeks)
• Control group: Standard care alone

Participants

• 130 patients (65 per group) with alcohol dependence syndrome
• Ages 18-65, completed acute detox (minimum 7 days abstinent)
• Must have protracted withdrawal symptoms

Primary ObjectiveDetermine if NAC reduces protracted withdrawal symptom severity compared to standard treatment alone

Key Assessments

• Primary outcome: Change in Alcohol Withdrawal Symptom Checklist (AWSC) scores at 8 weeks
• Secondary outcomes: Alcohol craving, depression, anxiety, sleep quality, and cognitive function
• Assessments at baseline, 4 weeks, and 8 weeks

SignificanceThis 12-month study (July 2025-June 2026) could provide evidence for integrating NAC into standard alcohol dependence treatment protocols, potentially improving outcomes and reducing relapse rates in patients experiencing protracted withdrawal symptoms.