ROLE OF NICOTINE GUMS, NICOTINE PATCHES AND BEHAVIOURAL COUNSELLING IN QUITTING TOBACCO HABIT

Phase 4

Not yet recruiting

Conditions: Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria

Registration Number: CTRI/2021/10/037366

Lead Sponsor: Cipla Pharmaceutical Company

Brief Summary: Tobacco use is a leading cause of preventabledeaths all over the world and worldwidethere are nearly1.2 billion users of nicotine and tobacco products causing morethan 5million deaths per year. Across studies, it has been found that themorbidity and mortality associated with tobacco use are substantially reducedby its complete cessation. The rationale of nicotine replacing therapy for nicotinedependence treatment is based on theory of harm reduction by making it easier toreplace the nicotine obtained from tobacco thereby providing nicotine mediatedneuropharmacological effect. As per Global AdultTobacco Survey India (GATS 2, 2016-17) 42.4% of men, 14.2% ofwomen and 28.6% (266.8 million) of all adults use tobacco (smoked and/orsmokeless tobacco), while in Odisha 45.6% of adults ( >15 years) are tobaccousers from which 2.8% are smoked, 38.6%are smokeless and 4.3% are both smoked and smokeless tobacco users. Despite of such prevalence of tobacco use inIndia, very few studies have been done for tobacco cessation using Nicotinereplacement therapy as an intervention and not a single such study has yet beendone in Odisha.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria and residing within 100Km from the institution.

Exclusion Criteria

Tobacco users with unstable angina, severe cardiac arrhythmia, recent acute myocardial infarction or cerebrovascular accident in preceding 3 months, pregnant and breast feeding women and tobacco users with a previous history of failure to NRT will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tobacco abstinence rate	6 months and 12 months

Secondary Outcome Measures

Name	Time	Method
comparing effect of different therapies on cessation of smoking and smokeless tobacco.	6 months and 12 months
the oral health status	baseline, 3 months, 6 months & 12 months
tobacco dependency	baseline, 3 months, 6 months and 12 months

Trial Locations

Locations (1): Tobacco Cessation Center, S.C.B Dental College
🇮🇳
Cuttack, ORISSA, India
Tobacco Cessation Center, S.C.B Dental College
🇮🇳Cuttack, ORISSA, India
Dr Kumar Kuldeep
Principal investigator
9438222603
kkuldeep583@gmail.com