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CTRI Number  CTRI/2025/07/091238 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does N-Acetylcysteine help reduce symptoms that persist after stopping alcohol use? 
Scientific Title of Study   Efficacy of N-Acetylcysteine as Adjunctive Therapy in the Management of Protracted Alcohol Withdrawal Syndrome: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kartik Chaudhary 
Designation  First Year Post Graduation Resident 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Psychiatry, KIMS, KIIT Campus-5, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  09785845750  
Fax    
Email  ckartik90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudipta Kumar Das 
Designation  HOD and Professor 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Psychiatry, KIMS, KIIT Campus-5, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  9439728347  
Fax    
Email  linksudipta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kartik Chaudhary 
Designation  First Year Post Graduation Resident 
Affiliation  Kalinga Institute of Medical Sciences, Bhubaneswar 
Address  Department of Psychiatry, KIMS, KIIT Campus-5, Patia, Bhubaneswar

Khordha
ORISSA
751024
India 
Phone  09785845750  
Fax    
Email  ckartik90@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha, India, 751024 
 
Primary Sponsor  
Name  Dr Kartik Chaudhary 
Address  Post Graduation Resident, Department of Psychiatry, KIMS, Bhubaneswar, Odisha, India, 751024 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kartik Chaudhary  Kalinga Institute of Medical Sciences  KIIT Campus-5, Patia, Bhubaneswar, Odisha
Khordha
ORISSA 		 09785845750

ckartik90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, KIIT deemed-to-be-University, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F102||Alcohol dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  N-Acetylcysteine  N-Acetylcysteine as oral tablets up to 2400mg/day given as an adjunct to the treatment as usual, for 8 weeks 
Comparator Agent  Treatment as usual  Treatment as usual, for 8 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in the Alcohol Withdrawal Symptom Checklist (AWSC) score at 8 weeks.  Day 0, 28 and 56 
 
Secondary Outcome  
Outcome  TimePoints 
Penn Alcohol Craving Scale, Visual Analog Scale for Craving, Hamilton Anxiety Rating Scale, Hamilton Depression Rating Scale, Pittsburgh Sleep Quality Index, Montreal Cognitive Assessment  Day 0, 28 and 56 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 Design

Randomized 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 Objective

Determine 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

Significance

This 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.

 
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