| CTRI Number |
CTRI/2025/08/093177 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Studying the use of N-acetyl cysteine as an additional treatment to help patients with alcohol dependence, using brain imaging to measure its effects. |
|
Scientific Title of Study
|
Adjunctive N-Acetyl Cysteine on craving in patients with alcohol dependence syndrome and its neurometabolite correlates: an H MRS based study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Rana |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Room no. 36, AL Razi post graduate hostel, Central
Institute of Psychiatry, Kanke Ranchi, Jharkhand
Kanke, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
7018275112 |
| Fax |
|
| Email |
vjrana8628@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Munda |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Consultant room, SS Raju Centre of Addiction Psychiatry, Central
Institute of Psychiatry, Kanke Ranchi, Jharkhand
Kanke, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8797641082 |
| Fax |
|
| Email |
drsanjaymunda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surendra Paliwal |
| Designation |
Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Consultant Room, Central Institute of Psychiatry, Kanke Ranchi
Kanke, Ranchi
Ranchi
JHARKHAND
834006
India |
| Phone |
8005940887 |
| Fax |
|
| Email |
itsme.paliwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Ranchi, Jharkhand 834006 |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry Kanke Ranchi Jharkhand 834006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Rana |
SS Raju Centre of Addiction Psychiatry, Central Institute of Psychiatry |
Research Lab, 2nd floor, SS Raju Centre of Addiction Psychiatry, Department of Psychiatry, Central
Institute of Psychiatry, Kanke Ranchi
Ranchi
JHARKHAND |
7018275112
vjrana8628@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Central Institute of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
N-acetyl Cysteine |
N-acetyl Cysteine , 2400mg/d in two divided doses to be given for 30 days |
| Comparator Agent |
Recieve Treatment as usual |
Recieve Treatment as usual |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Male patients diagnosed with Alcohol Dependence
Syndrome as per International Classification of
Disease - 11th revision -Diagnostic Criteria for
Research.
2. Age between 18 to 60 years
3. Patients with history of relapse.
4. The Clinical Institute Withdrawal Assessment for
Alcohol (revised version) CIWA-Ar lesser than or
equal to 10.
5. Right-handed
6. Patients who are ready to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Alcohol dependence having any other co-morbid substance
dependence
2. Patients having any medical illness
3. Patients having any other psychiatric illness, organic brain disorder,
clinically diagnosed intellectual disability.
4. Patients having any metallic implants/ parts in body.
5. Severity of Alcohol Dependence Questionnaire (SADQ) less than 16 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in craving as measured by Alcohol craving questionnaire (ACQ-NOW) and Obsessive compulsive drinking scale
|
0th and 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Significant difference in level of Gluatamte after administration of adjuvanr N Acetyl Cysteine over treatment as usual |
0th and 4th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This proposed hospital-based, open-label clinical trial at the Central Institute of Psychiatry aims to assess the efficacy of adjunctive N-Acetyl Cysteine (NAC) (2400 mg/day) on alcohol craving and brain glutamate levels in the nucleus accumbens over a 4-weekperiod. A total of 40 right-handed male ADS patients aged 18–60 years, post-detoxification, will be randomized into two groups: one receiving NAC with treatment as usual (TAU) and the other receiving only TAU. Craving will be measured using validated tools like ACQ-NOW and OCDS, and glutamate levels will be assessed through Proton Magnetic Resonance Spectroscopy (MRS). Weekly monitoring for side effects will be conducted using the SAFTEE checklist. Statistical analysis will include comparison of craving scores and glutamate levels between groups and correlation with socio-demographic and clinical variables. This study seeks to explore NAC as a novel, safe, and effective adjunct treatment for reducing craving and relapse in ADS, with a neurobiological basis. |