Effectiveness of Different THR Products in Adult Population
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
The study is a two-arm, double blind, parallel randomized controlled trial (RCT) with a
treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258
smokers from general adult population. Participants who meet the eligibility criteria and
give their informed consent will be randomized (1:1) to one of two treatment arms: (1)
E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with
individual counselling. Eligible participants include both genders of at least 18 years of
age, self-identified as regular smokers (≥10 cigarettes per day for at least one year) and
motivated to quit. Participants will complete a total of ten visits including screening visit
and baseline visit along with eight study visits. Participants will complete telephone
follow-ups at weeks 1, 2, 8 and 18. They will come to site for screening visit, baseline line
visit and study visits at weeks 4, 12, 24, and 52. Biochemically validated smoking abstinence
will be measured at trial site using exhaled carbon monoxide (exhaled carbon monoxide ≥ 10
ppm will be considered an indicator of current smoking). At all follow-up calls and visits,
information about self-reported smoking, e-cigarette/nicotine patch use, use of other smoking
cessation therapies, withdrawal symptoms, and side effects will be collected.