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CTRI Number  CTRI/2025/02/080084 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 13/04/2025
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   Study on the Effectiveness of High Definition-Transcranial Direct Current Stimulation (HD-tDCS) in Reducing Alcohol Cravings in People with Alcohol Dependence 
Scientific Title of Study   Efficacy of High Definition-Transcranial Direct Current Stimulation (HD-tDCS) in Patients with Alcohol Dependence Syndrome (ADS) in Reducing Alcohol Cravings 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditya Rajan Shukla  
Designation  M.pharm (2nd year) Research Scholar 
Affiliation  Shri Guru Ram Rai University 
Address  Department of Pharmacy Practice, School of Pharmaceutical Sciences, shri Guru Ram Rai University, Patel Nagar, Dehradun (248001), Uttarakhand, India

Dehradun
UTTARANCHAL
248001
India 
Phone  7037444929  
Fax    
Email  shuklaadityarajan1696@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobit Garg  
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical Health & Sciences 
Address  Department of Psychiatry, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun (248001), Uttarakhand, India

Dehradun
UTTARANCHAL
248001
India 
Phone  8958534261  
Fax    
Email  shobit.garg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanishk Kala 
Designation  Assistant Professor  
Affiliation  Shri Guru Ram Rai University 
Address  Department of Pharmacy Practice, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Patel Nagar, Dehradun (248001), Uttarakhand, India

Dehradun
UTTARANCHAL
248001
India 
Phone  7451074773  
Fax    
Email  kanishk.kala@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Ram Rai University, Patel Nagar, Dehradun (248001), Uttarakhand, India 
Shri Mahant Indresh Hospital, Patel Nagar, Dehradun (248001), Uttarakhand, India 
 
Primary Sponsor  
Name  Aditya Rajan Shukla 
Address  Department of Pharmacy Practice, School of Pharmaceutical Sciences, Shri Guru Ram Rai University, Patel Nagar, Dehradun (248001), Uttarakhand, India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aditya Rajan Shukla   Shri Mahant Indresh Hospital  Room no.92, Neurocognitive Lab, Department of Psychiatry, second floor, south block
Dehradun
UTTARANCHAL 		 7037444929

shuklaadityarajan1696@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) Shri Guru Ram Rai Institute of Medical Health & Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High Definition-Transcranial Direct Current Stimulation (HD-tDCS): Active Stimulation  HD-tDCS Protocol: Participants will receive 20-minute sessions of HD-tDCS at 2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation. (during the trial/study of 6 months)  
Comparator Agent  High Definition-Transcranial Direct Current Stimulation (HD-tDCS): Sham timulation  Sham Stimulation: The sham group will receive 20-minute sessions of HD-tDCS at 0.2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation. (during the trial/study of 6 months) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  (1) Met criteria for alcohol dependence according to the International Classification of Disorders. (ICD-10-CM Diagnosis Code F10.2)
(2) Prior to participation, participants will give written, informed consent. 
 
ExclusionCriteria 
Details  (1) A condition of intoxication or withdrawal due to a substance other than alcohol.
(2) Diagnosis of epilepsy, convulsions, or delirium tremens during the abstinence of alcohol.
(3) A previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol.
(4) Any contraindication for electrical brain stimulation procedures such as electronic or metal implants. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Demonstration of the effectiveness of HD-tDCS in reducing alcohol cravings  3-point assessment will be done i.e., baseline, at the end of 2nd week & at the end of 4th week, during the trial. 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of tolerability, cognitive & emotional changes associated with HD-tDCS treatment.  3-point assessment will be done i.e., baseline, at the end of 2nd week & at the end of 4th week, during the trial.  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/02/2025 
Date of Study Completion (India) 13/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shuklaadityarajan1696@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 16-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Scores of various scales of every participant on every assessment point will be recorded and shared only for the purpose of meta-analysis or any development for TDCS studies. One must sign a non-disclosure agreement in order to access these IPD data
Brief Summary
Modification(s)  		 This study is a randomised, single-blind, parallel-group, single-center trial of High Definition-Transcranial Direct Current Stimulation (HD-tDCS) in 50 Patients with Alcohol Dependence Syndrome (ADS) in Reducing Alcohol Cravings for 6 months (approax.) to demonstrate the effectiveness of HD-tDCS in reducing alcohol cravings and identification of tolerability, cognitive, and emotional changes associated with HD-tDCS treatment 

Procedure

· HD-tDCS Protocol: Participants will receive 20-minute sessions of HD-tDCS at 2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation.

· Sham Stimulation: The sham group will receive 20-minute sessions of HD-tDCS at 0.2 mA intensity, 5 days per week, for 2 weeks. The anode will be placed over the left DLPFC (F3 position; beam F3), and 4 cathodes surrounding the area of stimulation.

SCALES

1. Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-AR)

2. Penn Alcohol Craving Scale (PACS)

3. Barratt Impulsivity Scale-11 (BIS-11)

 
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