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

NCT05639790 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Smoore Technology Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-04-30
Completion
2024-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639790 on ClinicalTrials.gov