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

Efficacy of Nicotine replacement therapy in combination with Behavioural counselling & m-cessation as compared to only Behavioural counselling & m-cessation on tobacco abstinence rate among Indian smokers: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/09/036425

Enrollment

116

Registered

2021-09-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: h NRT (Nicotine gums) in combination with Behavioural counselling and m-cessation: duration of the study 3 months gums containing 2mg of nicotine. Initial dosage will be 1-2 pieces ev

repeat this chew and park procedure for about 30 minutes or until the tingling or taste does not return. They will be asked to rotate the gum to different places between their cheeks and gums each t

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Subjective : Self reported abstinence rate Objective : Urine cotinine levelsTimepoint: Baseline or first visit At second TCC visit (1 week of quit date) At 3rd TCC visit ( 1 month of quit date) At 4th TCC visit (3 months of quit date)	—

Secondary

Measure	Time frame
Withdrawal symptoms and reduction in quantity and frequency of tobacco useTimepoint: At second TCC visit (1 week of quit date) At 3rd TCC visit ( 1 month of quit date) At 4th TCC visit (3 months of quit date)	—

Countries

India

Contacts

Public ContactDr Parul Kashyap

Sudha Rustagi College of Dental Sciences and Research Faridabad

maryacm@yahoo.co.uk9811144408

Outcome results