CTRI

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CTRI Number

CTRI/2025/09/094875 [Registered on: 16/09/2025] Trial Registered Prospectively

Last Modified On:

20/02/2026

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

A study to find out whether magnetic brain stimulation can help reduce alcohol craving in patients with alcohol use disorder

Scientific Title of Study

Effect Of Repetitive Transcranial Magnetic Stimulation On Craving In Patients With Alcohol Use Disorder : A Randomized Controlled Trail

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 Rahul Gautam
Designation	Postgraduate Junior resident
Affiliation	Sarojini Naidu Medical College, AGRA
Address	Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Agra UTTAR PRADESH 282003 India
Phone	7678817636
Fax
Email	ragautam0396@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vishal Sinha
Designation	Professor & Head of Department of Psychiatry
Affiliation	Sarojini Naidu Medical College ,AGRA
Address	Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Agra UTTAR PRADESH 282003 India
Phone	9719260778
Fax
Email	drvsinh2000@gmail.com

Details of Contact Person
Public Query

Name	Dr Rahul Gautam
Designation	Postgraduate Junior resident
Affiliation	Sarojini Naidu Medical College ,AGRA
Address	Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE Moti Katra AGRA UTTARPRADESH Agra UTTAR PRADESH 282003 India
Phone	7678817636
Fax
Email	ragautam0396@gmail.com

Source of Monetary or Material Support

SAROJINI NAIDU MEDICAL COLLEGE AGRA

Primary Sponsor

Name	Dr Rahul Gautam
Address	Department of Psychiatry SAROJINI NAIDU MEDICAL COLLEGE AGRA
Type of Sponsor	Other [Self]

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 Rahul Gautam	Sarojini Naidu Medical College and Hospital	Medicine block 2nd floor Department of Psychiatry Sarojini Naidu Medical College Moti Katra Agra Agra UTTAR PRADESH	7678817636 ragautam0396@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE SAROJINI NAIDU MEDICAL COLLEGE AGRA	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
Intervention	Active rTMS(REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION)	MACHINE MODEL USED-NEUROSOFT NEURO MS/D RTMS MACHINE WITH FIGURE OF 8 COIL Ten sessions of active-rtms stimulation over the right dorsolateral prefrontal cortex will be done and comparison between active hf-rtms and sham rtms will be done and outcome measures of alcohol craving over a follow-up period of 4 and 8 weeks using validated assessment tool like acq now and ocds scale will be done.
Comparator Agent	sham rTMS	MACHINE MODEL USED-NEUROSOFT NEURO MS/D RTMS MACHINE WITH FIGURE OF 8 COIL. Ten sessions of sham-rtms stimulation over the right dorsolateral prefrontal cortex will be done and comparison between active -rtms and sham rtms will be done and outcome measures of alcohol craving over a follow-up period of 4 and 8 weeks using validated assessment tool like acq and ocds scale will be done

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Patients Who Give Written Informed Consent. 2.Age Group Of 18-65 Years. 3.Patients Diagnosed As Having Alcohol Use Disorder (AUD) According To DSM-5TR. 4.Participants Should Be Medically Stable. 5.All AUD Patients Must Have Undergone At Least 7 To 10 Days Of Detoxification With Fixed Dose Reduction Regimen.

ExclusionCriteria

Details

1.Patients Of Epilepsy .
2.Any Metal Implant Or Magnetic Sensitive Implants In Or Near The Head Including Cochlear Implant, Aneurysm Clip, Metal Plates, Stents And Cardiac Pacemaker.
3.Patient Currently On Any Anti Craving Medication
4.Pregnant Or Lactating Female.
5.Recent Any Head Surgery.
6.Severe Or Acute Any Dermatological Condition On The Scalp Where rTMS Coil To Be Placed

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Alcohol Craving	1.BASELINE 2.4 WEEKS 3.8 WEEKS

Secondary Outcome

Outcome	TimePoints
NIL	NIL

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)

27/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

31/12/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="4"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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 thesis aims to determine the effect of Hf- rTMS on craving in patients with AUD and seeks to contribute to the development of more effective treatment strategy for reducing craving and establish long term efficacy in patient with Alcohol use disorder.

It Will Be A Double-Blind Randomized Controlled Trial In Recently Detoxified Patients With Alcohol Use Disorder,

Ten sessions Of Hf-Rtms (high frequency repetitive transcranial magnetic stimulation) Over The Right Dorsolateral Prefrontal Cortex Will Be Done And Comparison between

Active Hf-rTMS receiving group And Sham rTMS receiving group will be done and Outcome Measures Of Alcohol Craving Over a Follow-Up Period Of 4 And 8 Weeks Using Validated Assessment Tool Like Alcohol Craving Questionnaire And Obsessive Compulsive Drinking Scale will be done to assess change in alcohol craving.