ROLE OF NICOTINE GUMS, NICOTINE PATCHES AND BEHAVIOURAL COUNSELLING IN QUITTING TOBACCO HABIT
Phase 4
- Registration Number
- CTRI/2021/10/037366
- Lead Sponsor
- Cipla Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 rateTimepoint: 6 months and 12 months
- Secondary Outcome Measures
Name Time Method comparing effect of different therapies on cessation of smoking and smokeless tobacco.Timepoint: 6 months and 12 months;the oral health statusTimepoint: baseline, 3 months, 6 months & 12 months;tobacco dependencyTimepoint: baseline, 3 months, 6 months and 12 months