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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Combination Product: Electronic cigarettes + Health Counselling
* Other: Health Counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Counselling<br>Health counselling from a licensed mental health counselor | Other: Health Counselling<br>* Health Counselling from a licensed mental health counselor<br>|
| Experimental: Eletronic cigarette<br>Ad libitum use of electronic cigarettes for 1 month and health counselling from a licensed mental health counselor | Combination Product: Electronic cigarettes + Health Counselling<br>* Ad libitum use of electronic cigarettes for 1 month<br>Other: Health Counselling<br>* Health Counselling from a licensed mental health counselor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence | The effectiveness of smoking cessation with intervention | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of COPD-SQ questionnaire | self-reported score of COPD-SQ questionnaire | 1 month | 
| Score of COPD-PS questionnaire | self-reported score of COPD-PS questionnaire | 1 month | 
| Score of mMRC scale | self-reported score of modified Medical Research Council scale | 1 month | 
| Score of CAT questionnaire | self-reported score of COPD Assessment Test | 1 month | 
| %ratio of FEV1/FVC | the proportion of a person's vital capacity that are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). | 1 month | 
| Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) | Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine | 1 month | 
| Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) | Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) in urine | 1 month | 
| Concentration of 2-Cyanoethylmercaturic acid (CEMA) | Concentration of 2-Cyanoethylmercaturic acid (CEMA) in urine | 1 month | 
| Concentration of S-phenylmercapturic Acid (S-PMA) | Concentration of S-phenylmercapturic Acid (S-PMA) in urine | 1 month | 
| Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) | Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) in urine | 1 month | 
| Concentration of N-nitrosonornicotine (NNN) | Concentration of N-nitrosonornicotine (NNN) in urine | 1 month | 
| Concentration of S-benzyl-mercapturic acid (S-BMA) | Concentration of S-benzyl-mercapturic acid (S-BMA) in urine | 1 month | 
| Concentration of cotinine | Concentration of cotinine in urine | 1 month | 
| Concentration of Trans-3-Hydroxy Cotinine (TNE-2) | Concentration of Trans-3-Hydroxy Cotinine (TNE-2) in urine | 1 month | 
| Concentration of total Nicotine equivalent | Concentration of total Nicotine equivalent in urine | 1 month | 
| Concentration of formic acid | Concentration of formic acid in urine | 1 month |