Tobacco quitting therapy with or without m-cessation among Indian smokers

Phase 3

• Registration Number: CTRI/2021/09/036425
• Lead Sponsor: Dr Parul Kashyap self funded

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Both male and female subjects aged 18-50 years.

2. Subjects who are smoking an average of at least five cigarette/bidi/hukkah.

3. Subjects who are willing for further counselling after first health education counselling

session.

4. Subjects who are willing to come for follow up evaluations.

5. Participant having own mobile phone.

6. Are able to read Hindi and English.

Exclusion Criteria

1. Pregnant female subjects or planning for the same.

2. Subjects with systemic disease (like cardiac diseases, respiratory diseases etc).

3. Subjects who are not willing to give consent and who are with any substance abuse

disorder.

4. Subjects with high tobacco dependence (Fagerstrom scale >7)

5. Subjects with the history of hypersensitivity reaction toward nicotine.

6. Subjects with recent heart attack (within 2 weeks)

7. Subjects with unstable angina

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective : Self reported abstinence rate <br/ ><br> Objective : Urine cotinine levelsTimepoint: Baseline or <br/ ><br>first visit <br/ ><br>At second TCC <br/ ><br>visit (1 week of <br/ ><br>quit date) <br/ ><br>At 3rd TCC <br/ ><br>visit ( 1 <br/ ><br>month of <br/ ><br>quit date) <br/ ><br> <br/ ><br>At 4th TCC <br/ ><br>visit (3 <br/ ><br>months of <br/ ><br>quit date)

Secondary Outcome Measures

Name	Time	Method
Withdrawal symptoms and reduction in quantity and frequency of <br/ ><br>tobacco useTimepoint: At second TCC <br/ ><br>visit (1 week of <br/ ><br>quit date) <br/ ><br>At 3rd TCC <br/ ><br>visit ( 1 <br/ ><br>month of <br/ ><br>quit date) <br/ ><br> <br/ ><br>At 4th TCC <br/ ><br>visit (3 <br/ ><br>months of <br/ ><br>quit date) <br/ ><br>