NCT05639790

The Effectiveness of Using E-Cigarettes for Smoking Cessation and Decreasing Risk of Diseases Among Heavy Smokers

The Effectiveness of Using E-Cigarettes as Harm Reduction Strategy for Smoking Cessation and Decreasing Risk of Diseases Among Heavy Smokers: an Open-label Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shenzhen Smoore Technology Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate effectiveness of using e-cigarettes as harm reduction strategy for smoking cessation and decreasing risk of diseases in heavy smokers. The main questions it aims to answer are: * Is there any effectiveness of using E-cigarette as a harm reduction strategy for smoking cessation? * what are the impacts of using E-cigarette on respiratory function and risk of COPD? * Assess the exposure to harmful and potential harmful constituents (HPHCs) of using E-cigarette Participants will be randomized into a 6 months single-center, open label trial comparing study outcomes among 2 arms: health counselling, E-cigarette + health counselling. The EC arm will receive EC for 1 month. All 2 arms will receive health counselling from a licensed mental health counselor. After baseline, participants will report their use of combustible cigarette in both arms and EC use in the EC arm every day via online questionnaire in Wechat for behavioral monitoring. If there is a comparison group: Researchers will compare health counselling group to see if E-cigarrette intervention is an effective way to stop smoking, and if there any change in respiratory function and change in exposure to harmful and potential harmful constituents (HPHCs).

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Electronic cigarettes + Health Counselling	Ad libitum use of electronic cigarettes for 1 month
OTHER	Health Counselling	Health Counselling from a licensed mental health counselor

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-30
• Completion: 2024-08-01
• First posted: 2022-12-06
• Last updated: 2023-02-13