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

NCT05639790 | Withdrawn

• 1 other identifier: SR20221001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence abstinence

  The effectiveness of smoking cessation with intervention

  1 month

Secondary Outcomes (16)

• Score of COPD-SQ questionnaire

  1 month

• Score of COPD-PS questionnaire

  1 month

• Score of mMRC scale

  1 month

• Score of CAT questionnaire

  1 month

• %ratio of FEV1/FVC

  1 month

Study Arms (2)

Counselling

SHAM COMPARATOR

Health counselling from a licensed mental health counselor

Other: Health Counselling

Eletronic cigarette

EXPERIMENTAL

Ad libitum use of electronic cigarettes for 1 month and health counselling from a licensed mental health counselor

Combination Product: Electronic cigarettes + Health Counselling; Other: Health Counselling

Interventions

Electronic cigarettes + Health Counselling COMBINATION_PRODUCT

Ad libitum use of electronic cigarettes for 1 month

Eletronic cigarette

Health Counselling OTHER

Health Counselling from a licensed mental health counselor

Counselling; Eletronic cigarette

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old, gender is not limited
• The nicotine dependence test (FNDT) result score is 6-10 points
• Self-reported smoking at least 10 cigarettes a day, and smoking for at least 3 years
• Self-reported no current willingness to quit smoking
• Self-reported difficulty controlling the need to smoke, or smoking while sick in bed
• Must not accepted smoking cessation treatment in the last 3 months according to the self-report
• Must have never tried e-cigarette before
• Must be able to fully understand the purpose, nature and content of the research, and voluntarily sign the informed consent form as a subject
• Must agree and able to communicate well with the researcher, and able to complete the online questionnaire and examination in accordance with the research regulations.

You may not qualify if:

• Self-reported pregnant or breastfeeding
• Severe disease (defined as an illness or condition that put the patient at risk, interfere the trial results, or affect the patient's ability to participate in the trial judged by the panel)
• Past diagnosis of COPD, lung cancer, pneumoconiosis, bronchiectasis, interstitial lung disease, bronchial asthma, or other restrictive ventilatory disorder
• Living with severe heart, brain, liver, kidney, blood system diseases or malignant tumors
• Moderate-severe renal impairment, or creatinine clearance (CCr) ≤50ml/min
• Phenylpyruvaturia
• Allergic predisposition (be allergic to two or more substances), and is allergic to any of the components in e-cigarettes or e-liquid (e.g., benzoic acid, propylene glycol, glycerin, nicotine, etc.)
• Already been enrolled into a smoking cessation treatment, including but not limited to nicotine replacement therapy (NRT), varenicline, bupropion
• Living with mental illness, a history of chronic alcoholism, drug abuse, or any factor that affects compliance
• Participating in other clinical trials
• Life-threatening condition with a life expectancy less than 1 year
• Researcher believes that it is not suitable to participate in this researcher.

Sponsors & Collaborators

• Shenzhen Smoore Technology Limited: lead

MeSH Terms

Conditions

Smoking Cessation

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: December 6, 2022
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: August 1, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share