A double-blind, randomised study with repetitive transcranial magnetic stimulation and nicotine replacement therapy versus nicotine replacement therapy alone on cue-induced craving of both smoke and smokeless tobacco users.

This is a post-graduate thesis project started with the intent to evaluate the effect of repetitive Transcranial Magnetic Stimulation on the cue-induced craving of tobacco dependence, who are on Nicotine Replacement therapy. To study this aim we planned the objectives followed: Primary objective: To study the effectiveness of craving reduction in tobacco users by the rTMS intervention compared to sham-controlled. Secondary objectives: To study the quantity( number of chews or number of cigarettes) of consumption of tobacco use over the last 1 week. (self-report); To assess the change of severity of tobacco dependence; To assess the point prevalence of abstinence of tobacco use over the last 7 days (self-report). The design of this study is an experimental, double-blind, randomized controlled design. Study intervention is 20 Hz, 1200 pulses high frequency of rTMS on left DLPFC site with sham control. Study subjects will be recruited as a purposive sampling method at ESIC MCH, Hyderabad. The target sample size will be 30. study duration planned to conduct in 18 months duration from November 1st 2022 onwards.. potential study subjects will be selected with,

Inclusion Criteria:

1. Age: 18-60 years

2. Patients who have Nicotine dependence as per ICD-10.

3. Subjects who are cooperative and willing to give written informed consent for participation in the study.

4. Subjects who answer satisfactorily on a safety screening questionnaire for rTMS.

5. patients who started NRT for their tobacco dependence.

6. Mandatory 2 hours of abstinence from tobacco before the rTMS procedure.

7. Right-handedness individuals.

8. Patients with 5 or more failed other interventional methods.

G.Exclusion Criteria:

1. Patients with other active psychiatry disorders diagnosed according to DSM-5.

2. Use of any psychotropic medications on a regular basis.

3. Any other substance use disorder during the last 12 months.

4. History of epilepsy or increased risk of seizures for any reason.

5. Any significant neurological disorder or insult.

6. Patients with acute physical illness.

7. Known or suspected pregnancy or lactation.

8. Patients with intra-cranial implants, pacemakers, cochlear implants, implantation of medication pumps.

9)Patients who underwent DBS.

Study instruments that will be used to assess the dependence and cue-induced craving are Fagerstrom Test for Nicotine Dependence (FTND), Minnesota Nicotine Withdrawal Scale(MNWS) and Tobacco Cue Questionnaire (TCQ). These are used to assess the study objectives at baseline, after the 5th session, after the 10th session, 1 week and 1 month after the intervention.

Will take all ethical precautions and submit them to the institutional ethics committee and wait for approval.

Statistical analysis will be planned for parametric variables with paired t-test or chi-square test and ANOVA (smoker, smokeless tobacco users and dual users) are used and for the non-parametric variables, Wilcoxon rank-sum test or Fisher’s exact test and Kushal Wallis H test (smoker, smokeless tobacco users and dual users) are used.

Data analysis is done by using IBM SPSS Statistics software and the information is maintained confidential.