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Due to issues arised from the collaboration contract between sponsor and research site
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counselling | Sham Comparator | Health counselling from a licensed mental health counselor |
|
| Eletronic cigarette | Experimental | Ad libitum use of electronic cigarettes for 1 month and health counselling from a licensed mental health counselor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic cigarettes + Health Counselling | Combination Product | Ad libitum use of electronic cigarettes for 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day point prevalence abstinence | The effectiveness of smoking cessation with intervention | 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Health Counselling | Other | Health Counselling from a licensed mental health counselor |
|
| 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 |