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CTRI Number  CTRI/2024/10/075126 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 10/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Exploring how magnetic therapy can help reduce craving for Opioid 
Scientific Title of Study   A study of add-on rTMS on craving in patients with opioid dependence 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana Bhasin 
Designation  Junior Resident 
Affiliation  King George Medical University 
Address  Resident Room Ground Floor Department of Psychiatry Gate no 11 King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  9535072877  
Fax    
Email  bhasinsanjana.sb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Singh 
Designation  Assistant Professor 
Affiliation  King George Medical University 
Address  Ground Floor Chamber Department of Psychiatry Gate no 11 King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  8853817280  
Fax    
Email  amitsingh0612@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjana Bhasin 
Designation  Junior Resident 
Affiliation  King George Medical University 
Address  Resident Room Ground Floor Department of Psychiatry Gate no 11 King George Medical University

Lucknow
UTTAR PRADESH
226003
India 
Phone  9535072877  
Fax    
Email  bhasinsanjana.sb@gmail.com  
 
Source of Monetary or Material Support  
King George Medical University Shah mina road Chowk Lucknow Uttar Pradesh 226003 
 
Primary Sponsor  
Name  King George Medical University 
Address  King George Medical University Lucknow Uttar Pradesh 226003 226003 
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 Sanjana Bhasin  King George Medical University  Adult and Addiction Psychiatry OPD and Emergency Service Department of Psychiatry King George Medical University
Lucknow
UTTAR PRADESH 		 9535072877

bhasinsanjana.sb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King George Medical University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F112||Opioid dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active Repetitive transcranial magnetic stimulation rTMS  Patient will receive rTMS at 100% of RMT Patients receiving active rTMS will get 2 sessions at interval of 15 mins of intermittent theta burst simulation at 100% amplitude 5Hz 600 pulses in 20 trains with inter train interval of 8 secs and duration of the session will be 3 min 20 secs at left DLPFC for 5 days 
Comparator Agent  Sham rTMS  Patients receiving sham rTMS will get 2 sessions at interval of 15 mins of intermittent theta burst simulation at 0% amplitude 5Hz 600 pulses in 20 trains with inter train interval of 8 secs and duration of the session will be 3 min 20 secs at left DLPFC for 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Diagnosis of opioid dependence as per International Classification of Diseases 11th Revision ICD 11
Complete abstinence from opioids for at least 5 days
Clinical Opioid Withdrawal Scale COWS score of less than 5
Informed written consent from the patient 
 
ExclusionCriteria 
Details  A current diagnosis of any other psychiatric disorder except nicotine dependence and personality disorders
Any significant medical comorbidity requiring priority management
Not eligible to receive rTMS according to TMS screening checklist
Any patient who doesnt have the mental ability to comprehend the consent form 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the craving experienced by patients with opioid dependence receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.  Baseline
1 week
2 week
4 week 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the opioid use rates among patients with opioid dependence receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.  Baseline
1 week
2 week
4 week 
To compare the subjective well-being of patients with opioid dependance receiving antagonist treatment with add-on rTMS with those receiving antagonist treatment alone.  Baseline
1 week
2 week
4 week 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   22/10/2024 
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 - 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 [bhasinsanjana.sb@gmail.com].

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Repetitive Transcranial Magnetic Stimulation rTMS over the Prefrontal cortex PFC has a regulatory effect on mesolimbic and mesostriatal dopaminergic pathways We aim to study the effect of add-on rTMS on craving in patients with opioid dependence This is an interventional, single-blind randomised controlled study. The withdrawal symptoms of the patients will be managed and those with Clinical Opioid Withdrawal Scale COWS <5 and off benzodiazepines for 24 hrs will be included in this study. 48 patients will be recruited and randomly allocated in active and sham rTMS groups. TMS screening checklist will be applied for the eligibility of the participants. These patients will receive 2 sessions of rTMS over left DLPFC at a gap of 15 minutes for 5 days. Patients will be assessed at baseline, 1st, 2nd and 4th week. Craving will be assessed using Bried substance craving scale (BSCS) and Visual analog scale (VAS). Subjective well-being will be assessed using the WHO-5 well-being index. rTMS side-effect checklist and UKU side-effect checklist will be applied to monitor side effects. There are no risks as all necessary precautions will be taken. There are no known serious side effects of the intervention. Mild side effects include headache, muscle stiffness, scalp irritation, nausea, dizziness, fatigue/lightheadedness, and dry mouth. These side effects are temporary and may resolve on their own or with minimal medical care. There are no known long-term side effects of the intervention. After data collection, the data will be properly recorded in MS Excel following which it will be coded/recoded to an SPSS supported format. The data will then be transferred to SPSS v. 24 (IBM SPSS) for analysis. Association and correlation between the parameters shall be drawn using various analysis methods (such as student T-test, ANOVA, chi-square test, etc.) Proper conclusions will be drawn from the result of the analysis. We expect that rTMS will help reduce craving in patients and subsequently prevent opioid use among patients. While compared to standard forms of treatment, this study may help patients achieve improvement in their craving way earlier. This will significantly improve the quality of life of these patients. In the future, it can be used for the betterment of society. 
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