Smoking CessationNCT06801860
Chewing Gum for Smoking Cessation
A study testing Very brief smoking cessation advice, Chewing gum and Chewing gum usage leaflet in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Very brief smoking cessation advice, Chewing gum and Chewing gum usage leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Feb 2025to 30 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of Hong Kong aged 18 or above
- Smoking at least 1 cigarette per day over the past 3 months
- Have the habit of chewing gum or are willing to use chewing gum
- Participants who can communicate in Cantonese (including reading Chinese)
- Expressing an intention to quit or reduce smoking
- Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication
Who cannot join
- Having communication barriers (either physical or cognitive)
- Currently participating in other smoking cessation programs or services
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
School of Nursing, The University of Hong Kong
Hong Kong, Pokfulam, 999077
About this study
Official title: The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
The goal of this trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption, improved smoking cessation outcomes, and healthier oral health than the control group?
Researchers will compare chewing gum intervention to unassisted quitting to see if chewing gum works to cigarette reduction and smoking cessation.
Participants will:
- Receive very brief smoking cessation advice and booklet at baseline.
- Take chewing gum or unassisted quitting for 1 week.
- Conditions
- Smoking Cessation
- Being tested
- Very brief smoking cessation advice, Chewing gum, Chewing gum usage leaflet, 2-week reminder message
- Keywords
- Chewing gum, Behavioral intervention, Smoking cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very brief smoking cessation adviceBehavioural
All participants will receive very brief smoking cessation advice (guided by the AWARD model, assess, warning, refer, and do-it-again) with a smoking cessation information booklet onsite at baseline.
Chewing gumBehavioural
Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period.
Chewing gum usage leafletBehavioural
A leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.
2-week reminder messageBehavioural
A 2-week reminder message guided by the Love and Care approach will be delivered to participants twice a week (a total of four).
| Study group | Role | What they receive |
|---|---|---|
| Chewing gum | Experimental | Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage. Receives: Behavioral: Very brief smoking cessation advice; Behavioral: Chewing gum; Behavioral: Chewing gum usage leaflet; Behavioral: 2-week reminder message |
| Unassisted quitting | Active comparator | Participants in the unassisted quitting group (control group) will receive very brief smoking cessation advice (30 seconds) and a smoking cessation information booklet at baseline. Receives: Behavioral: Very brief smoking cessation advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validated abstinence
Biochemically validated smoking abstinence will be measured by saliva cotinine level (exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml)
Measured: 6-month follow-up
Secondary outcomes (12)
Number of pieces used
The number of pieces used will be measured by a self-designed question: "On average, how many pieces of gum do you use every day?"
Measured: 2-week, 3-month, and 6-month follow-ups
Frequency of use
The frequency of use will be measured by a self-designed question: "In the past seven days, how many days have you used chewing gum?"
Measured: 2-week, 3-month, and 6-month follow-ups
Duration of use
Duration of use will be measured by a self-designed question: "How long do you typically use it at a time?"
Measured: 2-week, 3-month, and 6-month follow-ups
Health effect
Health effect will be measured by a self-designed question: "Have you noticed any changes in your oral health after using chewing gum?"
Measured: 2-week, 3-month, and 6-month follow-ups
The biochemically validated smoking abstinence
Smoking abstinence is defined by exhaled CO <4 ppm and salivary cotinine <30ng/ml
Measured: 6-month follow-up
Self-reported 7-day point-prevalence abstinence
Smokers who did not smoke even a puff in the 7 days preceding the follow-up.
Measured: 2-week, 3-month, and 6-month
Self-reported smoking change
Self-reported change in number of cigarettes smoked daily of at least less 50% of the baseline number
Measured: 2-week, 3-month, and 6-month follow-ups
Self-reported self-efficacy of quitting
Self-reported self-efficacy of quitting includes the perception of quitting importance, difficulty, and confidence, assessing by an item scaled with 0-10, respectively. The score of zero refers to very unimportant, very easy, or very unconfident. The score of 10 refers to very important, very difficult, or very confident, respectively. Higher score refers to higher perception of quitting importance, difficulty, and confidence.
Measured: 2-week, 3-month, and 6-month follow-ups
Self-reported quit attempt
Self-reported quit attempt in the past 7 days.
Measured: 2-week, 3-month, and 6-month follow-ups
Nicotine dependence level
The nicotine dependence level will be measured by the Fagerstrom Test for Nicotine Dependence (FTND). The score ranges from 0 to 10, with higher scores indicating greater nicotine dependence.
Measured: 2-week, 3-month, and 6-month follow-ups
Smoking cessation services use
Using the smoking cessation service from hospitals or the government in Hong Kong
Measured: 2-week, 3-month, and 6-month follow-ups
Self-reported intention to quit
Self-reported intention to quit in the next days
Measured: 2-week, 3-month, and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start11 Feb 2025
- Primary completion26 Sep 2025
- Study completion30 Oct 2025
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Wang Man-Ping, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801860
- Sponsor's protocol ID
- Chew-to-Quit
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06801860
- Acronym / sponsor ID
- Chew-to-Quit
- Conditions
- Smoking Cessation
- Keywords
- Chewing gum, Behavioral intervention, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 30 Jan 2025 (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 trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption, improved smoking cessation outcomes, and healthier oral health than the control group?
Researchers will compare chewing gum intervention to unassisted quitting to see if chewing gum works to cigarette reduction and smoking cessation.
Participants will:
- Receive very brief smoking cessation advice and booklet at baseline.
- Take chewing gum or unassisted quitting for 1 week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewing gum | Experimental | Behavioral: Very brief smoking cessation advice, Behavioral: Chewing gum, Behavioral: Chewing gum usage leaflet, Behavioral: 2-week reminder messageParticipants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage. |
| Unassisted quitting | Active comparator | Behavioral: Very brief smoking cessation adviceParticipants in the unassisted quitting group (control group) will receive very brief smoking cessation advice (30 seconds) and a smoking cessation information booklet at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Residents of Hong Kong aged 18 or above
- Smoking at least 1 cigarette per day over the past 3 months
- Have the habit of chewing gum or are willing to use chewing gum
- Participants who can communicate in Cantonese (including reading Chinese)
- Expressing an intention to quit or reduce smoking
Key exclusion criteria (2 listed)
- Having communication barriers (either physical or cognitive)
- Currently participating in other smoking cessation programs or services
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 |
|---|---|---|
| Very brief smoking cessation adviceAll participants will receive very brief smoking cessation advice (guided by the AWARD model, assess, warning, refer, and do-it-again) with a smoking cessation information booklet onsite at baseline. | Behavioural | Chewing gum, Unassisted quitting |
| Chewing gumParticipants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. | Behavioural | Chewing gum |
| Chewing gum usage leafletA leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum. | Behavioural | Chewing gum |
| 2-week reminder messageA 2-week reminder message guided by the Love and Care approach will be delivered to participants twice a week (a total of four). | Behavioural | Chewing gum |
Primary outcome
Validated abstinence
Time frame: 6-month follow-up
Biochemically validated smoking abstinence will be measured by saliva cotinine level (exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml)
12 secondary outcomes
Number of pieces used
Time frame: 2-week, 3-month, and 6-month follow-ups
Frequency of use
Time frame: 2-week, 3-month, and 6-month follow-ups
Duration of use
Time frame: 2-week, 3-month, and 6-month follow-ups
Health effect
Time frame: 2-week, 3-month, and 6-month follow-ups
The biochemically validated smoking abstinence
Time frame: 6-month follow-up
Self-reported 7-day point-prevalence abstinence
Time frame: 2-week, 3-month, and 6-month
Self-reported smoking change
Time frame: 2-week, 3-month, and 6-month follow-ups
Self-reported self-efficacy of quitting
Time frame: 2-week, 3-month, and 6-month follow-ups
Self-reported quit attempt
Time frame: 2-week, 3-month, and 6-month follow-ups
Nicotine dependence level
Time frame: 2-week, 3-month, and 6-month follow-ups
Smoking cessation services use
Time frame: 2-week, 3-month, and 6-month follow-ups
Self-reported intention to quit
Time frame: 2-week, 3-month, and 6-month follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very brief smoking cessation advice, Chewing gum and Chewing gum usage leaflet in people with Smoking Cessation, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 1 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validated abstinence (time frame: 6-month follow-up). 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 1 Dec 2025; AzTrials last refreshed its copy on 3 Nov 2026.