Effectiveness of Different THR Products in Adult Population - Trial NCT05825924

Timeline & Enrollment

Primary Outcome

Point-prevalence abstinence

Summary

The study is a two-arm, 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 must be at least of legal age allowed for smoking in the country, of either
 gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to
 stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit
 at the trial site. The participants will be scheduled for eight study visits in total,
 including five treatment sessions and three follow-up visits, using both face to face
 interaction at trial site as well as follow up on telephone. Eight study visits are planned
 at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at
 the trial site to quantify biochemically validated smoking abstinence. All secondary outcomes
 and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout
 the study.

ICD-10 Classifications