Tobacco UseNCT06470776
Chatbot Counselling for Smoking Cessation in Youths
A study testing Chatbot counselling and Peer counselling in people with Tobacco Use and Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include: 1. To assess how many youth smokers accept the invitation to participate in the trial 2. Read more about this study
- Who is it for?
- Ages Up to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Smoking Cessation
- What is being tested?
- Chatbot counselling and Peer counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Jul 2024to 25 Jun 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 Up to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Hong Kong residents aged 25 years or younger
- Used a tobacco product in the past 30 days, including cigarettes, electronic cigarettes, heated tobacco products, etc.
- Able to communicate in Chinese
- Own a smartphone with internet access
Who cannot join
- Diagnosed with a mental disease or on regular psychotropic drugs, or
- Participating in other ongoing smoking cessation studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Chatbot for Smoking Cessation Counselling for Youth Smokers Enrolled in the Youth Quitline: a Pilot Randomised Trial
The goal of this pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include:
- To assess how many youth smokers accept the invitation to participate in the trial
- To assess the retention of the participants through 6 months after treatment initiation
- To assess the acceptability of the chatbot in terms of participants' compliance and usability rating of the chatbot.
- To estimate the intervention effect on abstinence outcomes
- To explore the participants' perception and experiences in the chatbot
- Conditions
- Tobacco Use, Smoking Cessation
- Being tested
- Chatbot counselling, Peer counselling
- Keywords
- conversational agent, virtual assistant, digital health, artificial intelligence, large language model, ChatGPT, adolescent
- Medical subject headings
- Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot counsellingBehavioural
Access to a chatbot that provides smoking cessation counselling based on the 5A's (Ask, Advice, Assess, Assist, Arrange follow-up) and 5R's (Risk, Relevance, Rewards, Relevance, Roadblocks, Repetition) tobacco intervention models from baseline to 3-month post-baseline.
Peer counsellingBehavioural
Usual treatment provided by the Youth Quitline, i.e., telephone counselling for smoking cessation based on the 5As and 5Rs models delivered by trained peer counsellors at baseline and 1 week, 1 month and 3 months post-baseline
| Study group | Role | What they receive |
|---|---|---|
| Chatbot counselling | Experimental | Smoking cessation counselling delivered by chatbot Receives: Behavioral: Chatbot counselling |
| Peer counselling | Active comparator | Smoking cessation counselling delivered by peer counsellors Receives: Behavioral: Peer counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-validated tobacco abstinence
Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)
Measured: 6 months after randomisation
Recruitment rate
Number of participants divided by the number of eligible subjects
Measured: Through recruitment completion, about 9 months
Retention rate
Number of participants completed the follow-up divided by the number of participants
Measured: 6 months
Secondary outcomes (8)
Self-reported 7-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 30 days
Measured: 3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 30 days
Measured: 6 months after randomisation
Self-reported 24-hour quit attempt
Serious attempt to quit smoking for 24 hours or longer in daily smokers
Measured: 3 months after randomisation
Self-reported 24-hour quit attempt
Serious attempt to quit smoking for 24 hours or longer in daily smokers
Measured: 6 months after randomisation
Self-reported 50% smoking reduction
Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers
Measured: 3 months after randomisation
Self-reported 50% smoking reduction
Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start7 Jul 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies 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
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- 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
- NCT06470776
- Sponsor's protocol ID
- 20212551
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2024
- Last updated
- 20 Nov 2025
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Chatbot for Smoking Cessation Counselling for Youth Smokers Enrolled in the Youth Quitline: a Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT06470776
- Acronym / sponsor ID
- 20212551
- Conditions
- Tobacco Use, Smoking Cessation
- Keywords
- conversational agent, virtual assistant, digital health, artificial intelligence, large language model, ChatGPT, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 24 Jun 2024 (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 pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include:
- To assess how many youth smokers accept the invitation to participate in the trial
- To assess the retention of the participants through 6 months after treatment initiation
- To assess the acceptability of the chatbot in terms of participants' compliance and usability rating of the chatbot.
- To estimate the intervention effect on abstinence outcomes
- To explore the participants' perception and experiences in the chatbot
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot counselling | Experimental | Behavioral: Chatbot counsellingSmoking cessation counselling delivered by chatbot |
| Peer counselling | Active comparator | Behavioral: Peer counsellingSmoking cessation counselling delivered by peer counsellors |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Hong Kong residents aged 25 years or younger
- Used a tobacco product in the past 30 days, including cigarettes, electronic cigarettes, heated tobacco products, etc.
- Able to communicate in Chinese
- Own a smartphone with internet access
Key exclusion criteria (2 listed)
- Diagnosed with a mental disease or on regular psychotropic drugs, or
- Participating in other ongoing smoking cessation studies.
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 |
|---|---|---|
| Chatbot counsellingAccess to a chatbot that provides smoking cessation counselling based on the 5A's (Ask, Advice, Assess, Assist, Arrange follow-up) and 5R's (Risk, Relevance, Rewards, Relevance, Roadblocks, Repetition) tobacco intervention models from baseline to 3-month post-baseline. | Behavioural | Chatbot counselling |
| Peer counsellingUsual treatment provided by the Youth Quitline, i.e., telephone counselling for smoking cessation based on the 5As and 5Rs models delivered by trained peer counsellors at baseline and 1 week, 1 month and 3 months post-baseline | Behavioural | Peer counselling |
Primary outcome
Biochemically-validated tobacco abstinence
Time frame: 6 months after randomisation
Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)
Recruitment rate
Time frame: Through recruitment completion, about 9 months
Number of participants divided by the number of eligible subjects
Retention rate
Time frame: 6 months
Number of participants completed the follow-up divided by the number of participants
8 secondary outcomes
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Time frame: 6 months after randomisation
Self-reported 24-hour quit attempt
Time frame: 3 months after randomisation
Self-reported 24-hour quit attempt
Time frame: 6 months after randomisation
Self-reported 50% smoking reduction
Time frame: 3 months after randomisation
Self-reported 50% smoking reduction
Time frame: 6 months after randomisation
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 20 Nov 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.
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 Chatbot counselling and Peer counselling in people with Tobacco Use and 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 4 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 20 Nov 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?
Biochemically-validated tobacco abstinence (time frame: 6 months after randomisation). The study lists 3 primary outcomes in all. 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 20 Nov 2025.