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CTRI Number  CTRI/2025/07/090808 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Using Brain Stimulation in Alcohol-Dependent Adults to Lower Cravings and Avoid Relapse 
Scientific Title of Study   Effectiveness of Transcranial Direct Current Stimulation in Craving Reduction and Relapse prevention in patients with Alcohol Dependence Syndrome - A Randomised Sham Controlled Study with Genetic Expression Profiling Analysis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Rajath Kumar K 
Designation  Post Graduate Student, Department of Psychiatry 
Affiliation  DHARWAD INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, DIMHANS 
Address  Department of Psychiatry, Dharwad Institute of Mental Health and Neurosciences (DIMHANS), Room No.2, DIMHANS Campus, Dharwad.
DIMHANS CAMPUS, Dharwad-Belgaum Rd, Saidapur, Dharwad.
Dharwad
KARNATAKA
580008
India 
Phone  9945552568  
Fax    
Email  rajathkumark01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Manjunath Bhajantri 
Designation  Associate Professor, Department of Psychiatry 
Affiliation  DHARWAD INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, DIMHANS 
Address  Department of Psychiatry, Dharwad Institute of Mental Health and Neurosciences (DIMHANS), Room No.1, DIMHANS Campus, Dharwad.
DIMHANS CAMPUS, Dharwad-Belgaum Rd, Saidapur, Dharwad.
Dharwad
KARNATAKA
580008
India 
Phone  9880772101  
Fax    
Email  rbmanjunath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Rajath Kumar K 
Designation  Post Graduate Student, Department of Psychiatry 
Affiliation  DHARWAD INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES, DIMHANS 
Address  Department of Psychiatry, Dharwad Institute of Mental Health and Neurosciences (DIMHANS), Room No.2, DIMHANS Campus, Dharwad.
DIMHANS CAMPUS, Dharwad-Belgaum Rd, Saidapur, Dharwad.
Dharwad
KARNATAKA
580008
India 
Phone  9945552568  
Fax    
Email  rajathkumark01@gmail.com  
 
Source of Monetary or Material Support  
Dharwad Institute of Mental Health and Neurosciences (DIMHANS), DIMHANS Campus, Dharwad. 
 
Primary Sponsor  
Name  Dharwad Institute of Mental Health and Neurosciences (DIMHANS) 
Address  Dharwad-Belgaum Rd, Saidapur, Dharwad, Karnataka 580008 
Type of Sponsor  Government medical college 
 
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 Rajath Kumar K  Dharwad Institute of Mental Health and Neurosciences   Department of Psychiatry, Dharwad Institute of Mental Health and Neurosciences (DIMHANS), Room No.2, DIMHANS Campus, Dharwad
Dharwad
KARNATAKA 		 9945552568

rajathkumark01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee(IEC) DIMHANS, Dharwad   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 
Comparator Agent  Sham Transcranial Direct Current Stimulation   Participants in the sham group will receive simulated tDCS using the same electrode placement(right anode at F4, left cathode at F3).Stimulation will be ramped up to 2 mA over 15 seconds, maintained briefly, then ramped down over 15 seconds. No current will be delivered for the remaining session duration. Total of 10 sessions over 14 days. 
Intervention  Transcranial Direct Current Stimulation (tDCS)  Participants will receive active transcranial direct current stimulation using 2 mA current applied for 20 min per session. Anode is placed over right dorsolateral prefrontal cortex(F4) and cathode over left DLPFC(F3).A total of 10 sessions will be delivered over 14 days. Stimulation will be ramped up and down over 15 seconds.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  1. Male patients aged between 18 and 55 years.
2. Diagnosed with Alcohol Dependence Syndrome as per ICD 11.
3. CIWA Ar score less than or equal to 10 at admission.
4. Not currently receiving anti craving medications.
5. OCDS score greater than 1.
6. Willing to provide informed consent and comply with study procedures. 
 
ExclusionCriteria 
Details  a) Patients who do not give informed consent for the study.
b) Patients with any other substance use disorder other than nicotine.
c) Patients who have received modified electroconvulsive therapy (mECT) or any other neuromodulation treatment in the past 6 months.
d) Patients with any significant neurological illness.
e) Presence of medical implants (e.g., pacemakers, defibrillators, brain aneurysm clips, cochlear implants).
f) Patients with any other contraindications to tDCS, including migraine and scalp skin lesions.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in alcohol craving scores as measured by the Obsessive Compulsive Drinking Scale(OCDS).  Baseline, 2 Weeks, 1 month post-intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Relapse rate in patients with Alcohol Dependence Syndrome.  1 month post intervention  
Change in gene expression levels (GRIN2B and GRIA1) from baseline to post-tDCS and follow-up  Baseline, post tDCS intervention, 1 month post intervention. 
Improvement in quality of life scores   1 month post-intervention 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   24/07/2025 
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 is a single-center, single-blind, randomized sham-controlled clinical trial conducted at a tertiary mental health institute in India. The study aims to evaluate the clinical efficacy of transcranial direct current stimulation (tDCS) in reducing craving and preventing relapse in male patients diagnosed with Alcohol Dependence Syndrome (ADS) as per ICD-11 criteria. In addition to clinical outcomes, the study will also investigate molecular changes by analyzing the gene expression of GRIN2B and GRIA1, which are associated with craving and neuroplasticity. Participants will be randomly assigned to receive either active or sham tDCS over 10 sessions within 14 days. Craving will be measured using the Obsessive Compulsive Drinking Scale (OCDS), and blood samples will be collected at baseline, post-intervention, and one-month follow-up to assess gene expression changes. The study hypothesizes that active tDCS will lead to a significant reduction in craving and relapse rates and result in favorable modulation of target gene expression compared to sham stimulation. 
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