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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05639790
• Other study ID #: SR20221001
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2023
• Source: Shenzhen Smoore Technology Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Smoore Technology Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence	The effectiveness of smoking cessation with intervention	1 month
Secondary	Score of COPD-SQ questionnaire	self-reported score of COPD-SQ questionnaire	1 month
Secondary	Score of COPD-PS questionnaire	self-reported score of COPD-PS questionnaire	1 month
Secondary	Score of mMRC scale	self-reported score of modified Medical Research Council scale	1 month
Secondary	Score of CAT questionnaire	self-reported score of COPD Assessment Test	1 month
Secondary	%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
Secondary	Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)	Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine	1 month
Secondary	Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA)	Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) in urine	1 month
Secondary	Concentration of 2-Cyanoethylmercaturic acid (CEMA)	Concentration of 2-Cyanoethylmercaturic acid (CEMA) in urine	1 month
Secondary	Concentration of S-phenylmercapturic Acid (S-PMA)	Concentration of S-phenylmercapturic Acid (S-PMA) in urine	1 month
Secondary	Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA)	Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) in urine	1 month
Secondary	Concentration of N-nitrosonornicotine (NNN)	Concentration of N-nitrosonornicotine (NNN) in urine	1 month
Secondary	Concentration of S-benzyl-mercapturic acid (S-BMA)	Concentration of S-benzyl-mercapturic acid (S-BMA) in urine	1 month
Secondary	Concentration of cotinine	Concentration of cotinine in urine	1 month
Secondary	Concentration of Trans-3-Hydroxy Cotinine (TNE-2)	Concentration of Trans-3-Hydroxy Cotinine (TNE-2) in urine	1 month
Secondary	Concentration of total Nicotine equivalent	Concentration of total Nicotine equivalent in urine	1 month
Secondary	Concentration of formic acid	Concentration of formic acid in urine	1 month