A good method to stop the tobacco smoking habit

Not yet recruiting

• Conditions: Other and unspecified lesions of oral mucosa,

• Registration Number: CTRI/2023/03/050989
• Lead Sponsor: Dr Milind Wasnik

Brief Summary

The current study is aimed to gauge the effectiveness of three different tobacco cessation interventions i.e. NRT (Nicotine Replacement therapy) alone, combination of NRT (Nicotine Replacement therapy) & counseling & combination of NRT (Nicotine Replacement therapy) and m-cessation among Chhattisgarh Population. A prospective, single-blind, randomized controlled interventional study would be carried out among patients attending the Tobacco Cessation Centre at Government Dental College, Raipur, Chhattisgarh, and a total of 150 participants who will satisfy the inclusion and exclusion criteria would be selected for the study. The selected study participants would be randomly and equally assigned to the three intervention groups (50 participants in each group) for a time span of 3 months . Participants were randomized on a 1:1:1 basis to the three groups using block randomization with variable block size of 3. Participants were randomly allocated to three different study groups composed of NRT group (Group I) (12 -week course), a combination of the both (Group II) (counseling intervention (30 min intervention with printed materials) with a 12 -week sequential course of NRT), and mCessation along with NRT (Group III). After intervention period, the abstinence from the tobacco use or decline in the frequency and quantity of tobacco use would be evaluated by a pretested questionnaire and clinical analysis of the participants by measuring the respired CO using the CO monitoring device, Nicotine Cotinine levels will be measured by Nicotine Cotinine tests in urine sample. this will help us to know that which method will be more helpful in quitting tobacco habit.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-04
• Last Update Posted: 2023-03-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Outpatients at the hospital, within the age band of 18– 60 years 2.
• Participants who remained current users of “smoking form†of tobacco 3.
• Confirmed to remain at their current address till the completion of the study.
• Able to provide written informed consent and understand the study protocol.
• Access to the mobile phones.

Exclusion Criteria

• Terminal ailment (prognosis <12 months) 2.
• Pregnancy 3.
• Patients under psychiatric care 4.
• History of hypersensitive reactions toward nicotine or menthol 5.
• Previous admission into the similar study 6.
• Patients using both smoking and smokeless variants of tobacco.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of various interventions used for tobacco cessation i.e. which method is more helpful in quitting tobacco habit	Effectiveness of various interventions used for tobacco cessation for Three Months.

Secondary Outcome Measures

Name	Time	Method
Pharmacotherapy with combination of behavioral therapy would yield in better results.	Effectiveness of various interventions used for tobacco cessation for Three Months.

Trial Locations

Locations (1)

Govt Dental College Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

Govt Dental College Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Milind Wasnik

Principal investigator

9403162220

drmilind.pcd@gmail.com