FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/11/016339 [Registered on: 15/11/2018] Trial Registered Prospectively
Last Modified On: 16/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of transcranial direct current stimulation on urges to smoke tobacco among opioid dependent smokers. 
Scientific Title of Study   A randomised single blind sham controlled trial to evaluate the effect of transcranial direct current stimulation (tDCS) on tobacco craving among opioid dependent smokers maintained on Buprenorphine 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preethy Kathiresan 
Designation  Senior Resident (Academic) 
Affiliation  AIIMS 
Address  Room no 4096 Psychiatry office 4th floor Teaching block Department of Psychiatry and NDDTC AIIMS New Delhi

South West
DELHI
110029
India 
Phone  8800565316  
Fax  01126588663  
Email  princyaiims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sonali Jhanjhee 
Designation  Professor 
Affiliation  AIIMS 
Address  Room no 4085 Psychiatry office 4th floor Teaching block Department of Psychiatry and NDDTC AIIMS New Delhi

South West
DELHI
110029
India 
Phone  01126594997  
Fax  01126588663  
Email  sonali_arj@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Sonali Jhanjhee 
Designation  Professor 
Affiliation  AIIMS 
Address  Room no 4085 Psychiatry office 4th floor Teaching block Department of Psychiatry and NDDTC AIIMS New Delhi

South West
DELHI
110029
India 
Phone  01126594997  
Fax  01126588663  
Email  sonali_arj@hotmail.com  
 
Source of Monetary or Material Support  
No monetary funding. Institute - AIIMS, Delhi 
 
Primary Sponsor  
Name  NIL 
Address  Not applicable 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preethy Kathiresan  Community Drug Treatment Clinic, Kotla, Mubarakpur, New Delhi  Drug Treatment Clinic 111/9, Opposite Sector B-4 Vasant Kunj Kotla Mubarakpur, South Extension, New Delhi, Delhi 110070
South
DELHI 		 8800565316

princyaiims@gmail.com 
Preethy Kathiresan  Community Drug Treatment Clinic, Trilokpuri  Community Drug Treatment Clinic, MIT Rotary Eye Hospital, AIIMS, Block 2, Trilokpuri, New Delhi - 110091
East
DELHI 		 8800565316

princyaiims@gmail.com 
Preethy Kathiresan  Community Opioid substitution therapy clinic, SunderNagari  Community Drug treatment clinic, Community centre, F2, Block, Sunder Nagari, New Delhi - 110093
North East
DELHI 		 8800565316

princyaiims@gmail.com 
Preethy Kathiresan  National Drug dependence treatment centre (NDDTC) , AIIMS, New Delhi  Outpatient block, Ward A, Ward B, NDDTC, Near CGO complex, Kamla nehru nagar, Ghaziabad - 201002
Ghaziabad
UTTAR PRADESH 		 8800565316

princyaiims@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research (Clinical Studies) , All India Institute of Medical Sciences, Ansari Nagar, New Delhi  Approved 
Institute Ethics Committee for Post Graduate Research (Clinical Studies), All India Institute of Medical Sciences, Ansari Nagar, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F172||Nicotine dependence, (2) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active tDCS  HC tDCS machine will be used in the study. Each subject will receive 5 sessions of tDCS with 1 session per day. The parameters that will be used in the study are as follows – Current of 2 mA will be used with anodal electrode being placed on the scalp over Left Dorsolateral prefrontal cortex and cathode on the scalp over Right Dorsolateral prefrontal Cortex. Each session will be applied for 20 minutes. Current will be delivered through the electrodes throughout the 20 minutes. The sessions will be delivered daily from Monday to Friday. However, if a person misses one session, the session will be continued from the next day and will not be counted as drop out. Total of 5 sessions will be given. If a person misses 2 sessions, then he will be counted as drop out and no further session will be provided. 
Comparator Agent  Sham tDCS  HC tDCS machine will be used in the study. Each subject will receive 5 sessions of tDCS with 1 session per day. The parameters that will be used in the study are as follows – Current of 2 mA will be used with anodal electrode being placed on the scalp over Left Dorsolateral prefrontal cortex and cathode on the scalp over Right Dorsolateral prefrontal Cortex. In the case of sham tDCS, machine will be kept on for initial 30 seconds and terminal 30 seconds of the 20 minute session and it will be switched off in between, so that patient can feel the sensation at the site of application similar to active tDCS, but at the same time, not receive the actual stimulation. The sessions will be delivered daily from Monday to Friday. However, if a person misses one session, the session will be continued from the next day and will not be counted as drop out. Total of 5 sessions will be given. If a person misses 2 sessions, then he will be counted as drop out and no further session will be provided. 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Male 
Details  Right handed
Patients maintained on Buprenorphine for more than or equal to 3 months
Current daily users of Tobacco by smoking route (Defined as Daily use of beedis or cigarettes
in the past 1 month)
Nicotine dependence as per ICD 10 criteria
Minimum duration of Tobacco smoking is more than or equal to 1 year
Smoking more than or equal to 10 cigarettes or beedis or both per day
Willing to give informed consent 
 
ExclusionCriteria 
Details  Current smokeless tobacco users (defined as using smokeless tobacco in past 1 month)
Currently undergoing tobacco cessation treatment (in past 1 month)
Current use of Benzodiazepines, Heroin, Tramadol, Dextropropoxyphene as confirmed by Urine Casette test
Current alcohol harmful use or dependence (as per ICD 10 criteria based on History)
Current cannabis harmful use or dependence (as per ICD 10 criteria based on History)
History of significant head injury, epilepsy, major psychiatric or neurological illness
(Based on history)
Presence of any metallic implants or devices or metalic rods or pacemakers, etc. (Based on
history and physical examination)
Inability to give consent (Due to Mental retardation / any illness ) 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1) Baseline tobacco craving by Brief Questionnaire of Smoking Urges (BQSU)
2) Cue induced tobacco craving by Visual Analog Scale 		 Before 1st session of tDCS
After 1st session of tDCS
After 5th session of tDCS 
 
Secondary Outcome  
Outcome  TimePoints 
Number of beedi/cigarette consumed per day  Before 1st session of tDCS and After 5th session of tDCS  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/12/2018 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Transcranial direct current stimulation is a non invasive neuromodulatory technique whose role is being currently explored in recent studies from western countries, among subjects with nicotine dependence to test its  effect on reducing craving to smoke and reduction in the number of cigarettes smoked.The current study is a randomised, single blind, parallel group sham controlled trial with primary objective to evaluate the effect of Transcranial direct current stimulation (tDCS) on tobacco craving among 30 opioid dependent adult male smokers who have been stabilised on Tablet Buprenorphine for opioid dependence for at least 3 months. The study will be conducted at National Drug Dependence Treatment Centre (NDDTC) and Community clinics of NDDTC. The primary outcomes that will be measured in this study are 1) Baseline tobacco craving by Brief Questionnaire of Smoking Urges and 2),. Cue induced tobacco craving by Visual Analog Scale. The secondary objectives of the study are 1) To find the effect of tDCS on cigarette/beedi consumption among opioid dependent smokers maintained on Buprenorphine maintenance for at least 3 months and 2) To find the association of socio-demographic data and clinical parameters like severity of nicotine dependence, motivation to stop smoking, etc. with change in craving and tobacco consumption due to  tDCS among opioid dependent smokers maintained on Buprenorphine maintenance for at least 3 months. Socio demographic data will be assessed using semi-structured proforma. Severity of nicotine dependence will be assessed using Fagerstrom’s test for nicotine dependence. Motivation to stop smoking will be assessed using motivation to stop scale.
 
Close