Tobacco SmokingQTW2023NCT05881083
Nicotine Replacement Therapy Sampling for Smokers in the Community
A study testing 1-week nicotine replacement therapy sampling and Brief cessation advice in people with Tobacco Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- 1-week nicotine replacement therapy sampling and Brief cessation advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,014 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 Jun 2023to 30 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 years or above
- Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
- Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
- Able to communicate in and read Chinese
- Have a local contact number
Who cannot join
- Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
- Pregnant or breastfeeding
- Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Community sites
Hong Kong
Tzu Tsun Luk
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2023: a Randomised Controlled Trial of 1-week Nicotine Replacement Therapy Sampling
The aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community.
- Conditions
- Tobacco Smoking
- Being tested
- 1-week nicotine replacement therapy sampling, Brief cessation advice
- Keywords
- smoking, tobacco, nicotine replacement therapy, lay counsellor
- Medical subject headings
- Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-week nicotine replacement therapy samplingBehavioural
Participants will be given an 1-week sample of nicotine replacement therapy (patch or gum) with brief instructions on how to use the product
Brief cessation adviceBehavioural
Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model:
A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 1-week nicotine replacement therapy sample + Brief cessation advice Receives: Behavioral: 1-week nicotine replacement therapy sampling; Behavioral: Brief cessation advice |
| Control group | Active comparator | Brief cessation advice Receives: Behavioral: Brief cessation advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated tobacco abstinence
Verified by a negative salivary cotinine test
Measured: 6 months
Secondary outcomes (9)
Biochemically validated tobacco abstinence
Verified by a negative salivary cotinine test
Measured: 3 months
Self-reported 7-day point-prevalence tobacco abstinence
Measured: 3 months
Self-reported 7-day point-prevalence tobacco abstinence
Measured: 6 months
Self-reported 24-hour quit attempt
Measured: 3 months
Self-reported 24-hour quit attempt
Measured: 6 months
Self-reported use of nicotine replacement therapy product
Measured: 3 months
Self-reported use of nicotine replacement therapy product
Measured: 6 months
Self-reported use of smoking cessation service
Measured: 3 months
Self-reported use of smoking cessation service
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start17 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881083
- Sponsor's protocol ID
- QTW2023
- Acronym
- QTW2023
- Status last verified
- Jul 2023
- First submitted
- 19 May 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2023: a Randomised Controlled Trial of 1-week Nicotine Replacement Therapy Sampling
- ClinicalTrials.gov ID
- NCT05881083
- Acronym / sponsor ID
- QTW2023 / QTW2023
- Conditions
- Tobacco Smoking
- Keywords
- smoking, tobacco, nicotine replacement therapy, lay counsellor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,014 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 17 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 31 May 2023 (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 aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: 1-week nicotine replacement therapy sampling, Behavioral: Brief cessation advice1-week nicotine replacement therapy sample + Brief cessation advice |
| Control group | Active comparator | Behavioral: Brief cessation adviceBrief cessation advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged 18 years or above
- Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
- Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
- Able to communicate in and read Chinese
- Have a local contact number
Key exclusion criteria (3 listed)
- Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
- Pregnant or breastfeeding
- Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks
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 |
|---|---|---|
| 1-week nicotine replacement therapy samplingParticipants will be given an 1-week sample of nicotine replacement therapy (patch or gum) with brief instructions on how to use the product | Behavioural | Intervention group |
| Brief cessation adviceParticipants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model: A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again | Behavioural | Control group, Intervention group |
Primary outcome
Biochemically validated tobacco abstinence
Time frame: 6 months
Verified by a negative salivary cotinine test
9 secondary outcomes
Biochemically validated tobacco abstinence
Time frame: 3 months
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 3 months
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 6 months
Self-reported 24-hour quit attempt
Time frame: 3 months
Self-reported 24-hour quit attempt
Time frame: 6 months
Self-reported use of nicotine replacement therapy product
Time frame: 3 months
Self-reported use of nicotine replacement therapy product
Time frame: 6 months
Self-reported use of smoking cessation service
Time frame: 3 months
Self-reported use of smoking cessation service
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 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.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-week nicotine replacement therapy sampling and Brief cessation advice in people with Tobacco Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu Tsun Luk, PhD, RN (+852-3917-7574, luktt@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated tobacco abstinence (time frame: 6 months). 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 11 Jul 2023.