Smoking CessationNCT05639790
The Effectiveness of Using E-Cigarettes for Smoking Cessation and Decreasing Risk of Diseases Among Heavy Smokers
A study testing Electronic cigarettes + Health Counselling and Health Counselling in people with Smoking Cessation, run by Shenzhen Smoore Technology Limited.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Electronic cigarettes + Health Counselling and Health Counselling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
About this study
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
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
Read more
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).
- Conditions
- Smoking Cessation
- Being tested
- Electronic cigarettes + Health Counselling, Health Counselling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic cigarettes + Health CounsellingCombination product
Ad libitum use of electronic cigarettes for 1 month
Health CounsellingOther
Health Counselling from a licensed mental health counselor
| Study group | Role | What they receive |
|---|---|---|
| Counselling | Sham comparator | Health counselling from a licensed mental health counselor Receives: Other: Health Counselling |
| Eletronic cigarette | Experimental | Ad libitum use of electronic cigarettes for 1 month and health counselling from a licensed mental health counselor Receives: Combination Product: Electronic cigarettes + Health Counselling; Other: Health Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
The effectiveness of smoking cessation with intervention
Measured: 1 month
Secondary outcomes (16)
Score of COPD-SQ questionnaire
self-reported score of COPD-SQ questionnaire
Measured: 1 month
Score of COPD-PS questionnaire
self-reported score of COPD-PS questionnaire
Measured: 1 month
Score of mMRC scale
self-reported score of modified Medical Research Council scale
Measured: 1 month
Score of CAT questionnaire
self-reported score of COPD Assessment Test
Measured: 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).
Measured: 1 month
Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in urine
Measured: 1 month
Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA)
Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA) in urine
Measured: 1 month
Concentration of 2-Cyanoethylmercaturic acid (CEMA)
Concentration of 2-Cyanoethylmercaturic acid (CEMA) in urine
Measured: 1 month
Concentration of S-phenylmercapturic Acid (S-PMA)
Concentration of S-phenylmercapturic Acid (S-PMA) in urine
Measured: 1 month
Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA)
Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA) in urine
Measured: 1 month
Concentration of N-nitrosonornicotine (NNN)
Concentration of N-nitrosonornicotine (NNN) in urine
Measured: 1 month
Concentration of S-benzyl-mercapturic acid (S-BMA)
Concentration of S-benzyl-mercapturic acid (S-BMA) in urine
Measured: 1 month
Concentration of cotinine
Concentration of cotinine in urine
Measured: 1 month
Concentration of Trans-3-Hydroxy Cotinine (TNE-2)
Concentration of Trans-3-Hydroxy Cotinine (TNE-2) in urine
Measured: 1 month
Concentration of total Nicotine equivalent
Concentration of total Nicotine equivalent in urine
Measured: 1 month
Concentration of formic acid
Concentration of formic acid in urine
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Nov 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Why it stopped: Due to issues arised from the collaboration contract between sponsor and research site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Smoore Technology Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639790
- Sponsor's protocol ID
- SR20221001
- Status last verified
- Feb 2023
- First submitted
- 3 Nov 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05639790
- Acronym / sponsor ID
- SR20221001
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to issues arised from the collaboration contract between sponsor and research site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shenzhen Smoore Technology LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselling | Sham comparator | Other: Health CounsellingHealth counselling from a licensed mental health counselor |
| Eletronic cigarette | Experimental | Combination Product: Electronic cigarettes + Health Counselling, Other: Health CounsellingAd libitum use of electronic cigarettes for 1 month and health counselling from a licensed mental health counselor |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic cigarettes + Health CounsellingAd libitum use of electronic cigarettes for 1 month | Combination product | Eletronic cigarette |
| Health CounsellingHealth Counselling from a licensed mental health counselor | Other | Counselling, Eletronic cigarette |
Primary outcome
7-day point prevalence abstinence
Time frame: 1 month
The effectiveness of smoking cessation with intervention
16 secondary outcomes
Score of COPD-SQ questionnaire
Time frame: 1 month
Score of COPD-PS questionnaire
Time frame: 1 month
Score of mMRC scale
Time frame: 1 month
Score of CAT questionnaire
Time frame: 1 month
%ratio of FEV1/FVC
Time frame: 1 month
Concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Time frame: 1 month
Concentration of 3-Hydroxypropyl- mercapturic acid (3-HPMA)
Time frame: 1 month
Concentration of 2-Cyanoethylmercaturic acid (CEMA)
Time frame: 1 month
Concentration of S-phenylmercapturic Acid (S-PMA)
Time frame: 1 month
Concentration of 3-Hydroxy-1-methylpropyl-mercapturic acid (3-HMPMA)
Time frame: 1 month
Concentration of N-nitrosonornicotine (NNN)
Time frame: 1 month
Concentration of S-benzyl-mercapturic acid (S-BMA)
Time frame: 1 month
Concentration of cotinine
Time frame: 1 month
Concentration of Trans-3-Hydroxy Cotinine (TNE-2)
Time frame: 1 month
Concentration of total Nicotine equivalent
Time frame: 1 month
Concentration of formic acid
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic cigarettes + Health Counselling and Health Counselling in people with Smoking Cessation, run by Shenzhen Smoore Technology Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.