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Effectiveness of repetitive trans magnetic stimulation on craving among the tobacco users

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. - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069895
Enrollment
30
Registered
2024-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F172- Nicotine dependence

Interventions

Intervention1: Repetitive Trans Magnetic Stimulation: Site of pulses: Left DLPFC Target method:5 cm anterior and lateral to thumb area Number of sessions: 10 Frequency:20Hz Intensity (%RMT): 100% Tota

Sponsors

ESIC Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients who have Nicotine dependence as per ICD-10. 2) Subjects who are cooperative and willing to give written informed consent for participation in the study. 3) Subjects who answer satisfactorily on a safety screening questionnaire for rTMS. 4) patients who started NRT for their tobacco dependence. 5) Mandatory 2 hours of abstinence from tobacco before the rTMS procedure. 6) Right-handedness individuals. 7) Patients with 5 or more failed other interventional methods.

Exclusion criteria

Exclusion criteria: 1) Patients with other active psychiatry disorder diagnosed according to DSM-5. 2) Use of any psychotropic medications on a regular basis. 3) Any other substance use disorder during 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.

Design outcomes

Primary

MeasureTime frame
Craving reduction(cue induced)Timepoint: Baseline, after 5th session, after 10th session, 1 week follow up and 1 month follow up.

Secondary

MeasureTime frame
To assess the change of severity of tobacco dependence.Timepoint: Baseline, after 5th session, after 10th session, 1 week follow up and 1 month follow up.;To assess the point prevalence of abstinence of tobacco use since last 7 days ( self report).Timepoint: Baseline, after 5th session, after 10th session, 1 week follow up and 1 month follow up.;To study the quantity( number of chews or number of cigarettes) of consumption of tobacco use since last 1 week. ( self report)Timepoint: Baseline, after 5th session, after 10th session, 1 week follow up and 1 month follow up.

Countries

India

Contacts

Public ContactNukapeyya Santhosmitha

ESIC Medical College and Hospital, Sanathnagar, Hyderabad.

naveendhagudu@gmail.com8897848550

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026