Effectiveness of Different THR Products in Adult Population

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Foundation for a Smoke Free World INC
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Both genders of at least 18 years of age

• Smoked at least 10 cigarettes a day for the past one year

• Exhaled breath CO (eCO) level > 10 ppm

• Motivated to quit smoking or wishing to do so in the next 30 days according to Motivation to Stop Scale (MTSS) level 5 or higher

• Able to understand and provide informed consent

• Have a mobile phone

• Able to comply with all

Exclusion Criteria:

• Pregnant and breastfeeding women

• Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)

• Clients of a smoking cessation program or enrolled in another trial

• Any female participant who becomes pregnant during this study

• Contraindications to nicotine patches (i.e, they have had a heart attack, stroke or severe angina within the previous 2weeks) or e-cigarette (i.e, they self-report a history of severe allergies and/or poorly controlled asthma)

• Major illness with a prognosis of ≤ 1 year will also be excluded

• Medical/psychiatric history except those having disease prognosis with less than one year