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

N/AWithdrawnNCT05639790
Shenzhen Smoore Technology Limited

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Conditions

Smoking Cessation

Interventions

Electronic cigarettes + Health CounsellingCOMBINATION_PRODUCT

Ad libitum use of electronic cigarettes for 1 month

Health CounsellingOTHER

Health Counselling from a licensed mental health counselor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:
Medical Language ↔ Plain English
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.

Outcomes

Primary Outcomes

7-day point prevalence abstinence

The effectiveness of smoking cessation with intervention

Time frame: 1 month

Secondary Outcomes

Score of COPD-SQ questionnaire

self-reported score of COPD-SQ questionnaire

Time frame: 1 month

Score of COPD-PS questionnaire

self-reported score of COPD-PS questionnaire

Time frame: 1 month

Score of mMRC scale

self-reported score of modified Medical Research Council scale

Time frame: 1 month

Score of CAT questionnaire

self-reported score of COPD Assessment Test

Time frame: 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).

Time frame: 1 month

Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine

Time frame: 1 month

Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA)

Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) in urine

Time frame: 1 month

Concentration of 2-Cyanoethylmercaturic acid (CEMA)

Concentration of 2-Cyanoethylmercaturic acid (CEMA) in urine

Time frame: 1 month

Concentration of S-phenylmercapturic Acid (S-PMA)

Concentration of S-phenylmercapturic Acid (S-PMA) in urine

Time frame: 1 month

Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA)

Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) in urine

Time frame: 1 month

Concentration of N-nitrosonornicotine (NNN)

Concentration of N-nitrosonornicotine (NNN) in urine

Time frame: 1 month

Concentration of S-benzyl-mercapturic acid (S-BMA)

Concentration of S-benzyl-mercapturic acid (S-BMA) in urine

Time frame: 1 month

Concentration of cotinine

Concentration of cotinine in urine

Time frame: 1 month

Concentration of Trans-3-Hydroxy Cotinine (TNE-2)

Concentration of Trans-3-Hydroxy Cotinine (TNE-2) in urine

Time frame: 1 month

Concentration of total Nicotine equivalent

Concentration of total Nicotine equivalent in urine

Time frame: 1 month

Concentration of formic acid

Concentration of formic acid in urine

Time frame: 1 month

Data from ClinicalTrials.gov

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