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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05639790
Recruitment Status : Not yet recruiting
First Posted : December 6, 2022
Last Update Posted : December 6, 2022
Sponsor:
Information provided by (Responsible Party):
Shenzhen Smoore Technology Limited

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).


Condition or disease Intervention/treatment Phase
Smoking Cessation Combination Product: Electronic cigarettes + Health Counselling Other: Health Counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Estimated Study Start Date : February 1, 2023
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Counselling
Health counselling from a licensed mental health counselor
Other: Health Counselling
Health Counselling from a licensed mental health counselor

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




Primary Outcome Measures :
  1. 7-day point prevalence abstinence [ Time Frame: 1 month ]
    The effectiveness of smoking cessation with intervention


Secondary Outcome Measures :
  1. Score of COPD-SQ questionnaire [ Time Frame: 1 month ]
    self-reported score of COPD-SQ questionnaire

  2. Score of COPD-PS questionnaire [ Time Frame: 1 month ]
    self-reported score of COPD-PS questionnaire

  3. Score of mMRC scale [ Time Frame: 1 month ]
    self-reported score of modified Medical Research Council scale

  4. Score of CAT questionnaire [ Time Frame: 1 month ]
    self-reported score of COPD Assessment Test

  5. %ratio of FEV1/FVC [ Time Frame: 1 month ]
    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).

  6. Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) [ Time Frame: 1 month ]
    Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine

  7. Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) [ Time Frame: 1 month ]
    Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) in urine

  8. Concentration of 2-Cyanoethylmercaturic acid (CEMA) [ Time Frame: 1 month ]
    Concentration of 2-Cyanoethylmercaturic acid (CEMA) in urine

  9. Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 1 month ]
    Concentration of S-phenylmercapturic Acid (S-PMA) in urine

  10. Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) [ Time Frame: 1 month ]
    Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) in urine

  11. Concentration of N-nitrosonornicotine (NNN) [ Time Frame: 1 month ]
    Concentration of N-nitrosonornicotine (NNN) in urine

  12. Concentration of S-benzyl-mercapturic acid (S-BMA) [ Time Frame: 1 month ]
    Concentration of S-benzyl-mercapturic acid (S-BMA) in urine

  13. Concentration of cotinine [ Time Frame: 1 month ]
    Concentration of cotinine in urine

  14. Concentration of Trans-3-Hydroxy Cotinine (TNE-2) [ Time Frame: 1 month ]
    Concentration of Trans-3-Hydroxy Cotinine (TNE-2) in urine

  15. Concentration of total Nicotine equivalent [ Time Frame: 1 month ]
    Concentration of total Nicotine equivalent in urine

  16. Concentration of formic acid [ Time Frame: 1 month ]
    Concentration of formic acid in urine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05639790


Contacts
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Contact: Xiaona Liu, Doctor +86 13922487856 xiaona.liu@smooretech.com

Locations
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China, Zhejiang
Sir Run Run Shaw Hospital Administrative Building, No.368, Xiasha Road, Qiantang District
Hangzhou, Zhejiang, China, 310016
Contact: Xiaona Liu, Doctor    +86 13922487856    xiaona.liu@smooretech.com   
Sponsors and Collaborators
Shenzhen Smoore Technology Limited
Investigators
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Study Director: Yanhui Liao, Doctor Sir Run Run Shaw Hospital
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Responsible Party: Shenzhen Smoore Technology Limited
ClinicalTrials.gov Identifier: NCT05639790    
Other Study ID Numbers: SR20221001
First Posted: December 6, 2022    Key Record Dates
Last Update Posted: December 6, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No