The W3-030 Trial 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. Participants will be recruited from the general population through outpatient, and/or walk-in clinics, and/or through advertising. 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. Smoking cessation/relapse prevention counselling will be provided to both groups for a minimum of 30 minutes at baseline, 10 minutes during telephone follow-ups, and 15 minutes at trial site visits (20 minutes at week 4). Counselling will be administered by trained study personnel and based on the local or (international guidelines, if local guidelines not available) for tobacco use cessation counselling. Eligible participants include both gender of at least 18 years of age, self-identified as regular smokers (≥10 cigarettes per day for a least one year), and motivated to quit. A total of ten visits will be scheduled during the trial including a screening visit, a baseline (BL) visit and eight study visits (at weeks 1, 2, 4, 8, 12, 18, 24 and 52). Participants will complete telephone follow ups at weeks 1, 2, 8 and 18. 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.
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.