Smoking CessationNCT06570070
AI-powered Smoking Cessation Intervention
A study testing 5A's/5R's advice, Brief leaflet on health warning and smoking cessation and Self-help smoking cessation booklet in people with Smoking Cessation and Mobile Health, run by Beijing Normal University at 1 site in China.
Trial summary
This study aims to explore the feasibility and effectiveness of AI-powered chatbot support in community smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Mobile Health
- What is being tested?
- 5A's/5R's advice, Brief leaflet on health warning and smoking cessation and Self-help smoking cessation booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- aged 18 and above, reside in Zhuhai for the next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- Having a smartphone and a WeChat account, being able to use WeChat skillfully.
Who cannot join
- Smokers who have communication barrier (either physically or cognitively);
- Smokers who are currently participating in other SC programmes or services
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Artificial Intelligence (AI)-Powered Intervention in Smoking Cessation
This study aims to explore the feasibility and effectiveness of AI-powered chatbot support in community smokers.
Read the detailed description
Smoking cessation remains one of the most significant public health challenges worldwide, with tobacco use being a leading cause of preventable death and disease. Despite extensive efforts, the success rates of smoking cessation programs remain low, necessitating innovative approaches to support individuals in their journey to quit smoking. Recently, artificial intelligence (AI) has opened new possibilities in healthcare, including the development of AI-powered chatbots that assist individuals in behavior change, such as quitting smoking.
This randomized controlled trial aims to investigate the effectiveness of AI-powered chatbot that simulates human counselors in promoting smoking cessation among community smokers. The AI-powered chatbot, equipped with personalized interactions and real-time support, offers scalable and cost-effective assistance, potentially making it an accessible alternative to human counseling. However, human counselors provide empathy, tailored advice, and a nuanced understanding of human behavior that AI may not fully replicate. This study will explore which approach the feasibility and effectiveness of AI-powered chatbot support in community smokers.
- Conditions
- Smoking Cessation, Mobile Health
- Being tested
- 5A's/5R's advice, Brief leaflet on health warning and smoking cessation, Self-help smoking cessation booklet, AI-powered chatbot support, Counselor individual support
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5A's/5R's adviceBehavioural
5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit.
Brief leaflet on health warning and smoking cessationOther
The contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting.
Self-help smoking cessation bookletOther
The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.
AI-powered chatbot supportBehavioural
Participants will receive three months of AI-powered chatbot, equipped with personalized interactions and real-time support, via WeChat.
Counselor individual supportBehavioural
Participants will receive three months of counselor-led individual support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.
| Study group | Role | What they receive |
|---|---|---|
| AI support group | Experimental | AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet Receives: Behavioral: 5A's/5R's advice; Other: Brief leaflet on health warning and smoking cessation; Other: Self-help smoking cessation booklet; Behavioral: AI-powered chatbot support |
| Counselor support group | Experimental | Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet Receives: Behavioral: 5A's/5R's advice; Other: Brief leaflet on health warning and smoking cessation; Other: Self-help smoking cessation booklet; Behavioral: Counselor individual support |
| Control group | Active comparator | 5A's/5R's advice + health warning leaflet+ Self-help booklet Receives: Behavioral: 5A's/5R's advice; Other: Brief leaflet on health warning and smoking cessation; Other: Self-help smoking cessation booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical validated quit rate at 6 months follow-up
The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
Measured: 6 months follow-up
Secondary outcomes (6)
Biochemical validated quit rate at 3 months follow-up
biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
Measured: 3 months follow-up
Self-reported 7-day point prevalence quit rate
Self-reported 7-day point prevalence quit rate in the two groups
Measured: 3 and 6 months follow-up
Smoking reduction rate
Rate of smoking reduction by at least half of baseline amount in the two groups
Measured: 3 and 6 months follow-up
Eligibility rate
the percentage of eligible smokers out of the total number of smokers screened
Measured: baseline
Consent rate
the percentage of eligible smokers who agree to participate out of the total number of eligible smokers
Measured: baseline
Percentage of Participant Engagement with E-Messages and Counselor Chats
This outcome measures the percentage of participants who engage with the intervention by reading e-messages and responding to counselor chat messages at least once during the 3-month follow-up period.
Measured: 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Jan 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570070
- Sponsor's protocol ID
- AI-powered cessation support
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial Intelligence (AI)-Powered Intervention in Smoking Cessation
- ClinicalTrials.gov ID
- NCT06570070
- Acronym / sponsor ID
- AI-powered cessation support
- Conditions
- Smoking Cessation, Mobile Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Beijing Normal UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 26 Aug 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.
This study aims to explore the feasibility and effectiveness of AI-powered chatbot support in community smokers.
Detailed description
Smoking cessation remains one of the most significant public health challenges worldwide, with tobacco use being a leading cause of preventable death and disease. Despite extensive efforts, the success rates of smoking cessation programs remain low, necessitating innovative approaches to support individuals in their journey to quit smoking. Recently, artificial intelligence (AI) has opened new possibilities in healthcare, including the development of AI-powered chatbots that assist individuals in behavior change, such as quitting smoking.
This randomized controlled trial aims to investigate the effectiveness of AI-powered chatbot that simulates human counselors in promoting smoking cessation among community smokers. The AI-powered chatbot, equipped with personalized interactions and real-time support, offers scalable and cost-effective assistance, potentially making it an accessible alternative to human counseling. However, human counselors provide empathy, tailored advice, and a nuanced understanding of human behavior that AI may not fully replicate. This study will explore which approach the feasibility and effectiveness of AI-powered chatbot support in community smokers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI support group | Experimental | Behavioral: 5A's/5R's advice, Other: Brief leaflet on health warning and smoking cessation, Other: Self-help smoking cessation booklet, Behavioral: AI-powered chatbot supportAI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet |
| Counselor support group | Experimental | Behavioral: 5A's/5R's advice, Other: Brief leaflet on health warning and smoking cessation, Other: Self-help smoking cessation booklet, Behavioral: Counselor individual supportCounselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet |
| Control group | Active comparator | Behavioral: 5A's/5R's advice, Other: Brief leaflet on health warning and smoking cessation, Other: Self-help smoking cessation booklet5A's/5R's advice + health warning leaflet+ Self-help booklet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 and above, reside in Zhuhai for the next 6 months;
- smoke at least 1 cigarette or use e-cigarettes daily;
- Having a smartphone and a WeChat account, being able to use WeChat skillfully.
Key exclusion criteria (2 listed)
- Smokers who have communication barrier (either physically or cognitively);
- Smokers who are currently participating in other SC programmes 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 |
|---|---|---|
| 5A's/5R's advice5A's (Ask, Advise, Assess, Assist, Arrange) for smokers who are ready to quit, and 5R's (relevance, risks, rewards, roadblocks, and repetition) for smokers who are not ready to quit. | Behavioural | AI support group, Control group, Counselor support group |
| Brief leaflet on health warning and smoking cessationThe contents of the leaflet include the absolute risk of smoking, diseases caused by active and second-hand smoking, horrible pictorial warnings of the health consequences of active and second-hand smoking, and the benefits of quitting. | Other | AI support group, Control group, Counselor support group |
| Self-help smoking cessation bookletThe contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc. | Other | AI support group, Control group, Counselor support group |
| AI-powered chatbot supportParticipants will receive three months of AI-powered chatbot, equipped with personalized interactions and real-time support, via WeChat. | Behavioural | AI support group |
| Counselor individual supportParticipants will receive three months of counselor-led individual support via WeChat. The regular messages and instant messaging on psychosocial support aim to provide cessation advice, increase self-efficacy and confidence, and social support and behavioral capacity of quitting. | Behavioural | Counselor support group |
Primary outcome
Biochemical validated quit rate at 6 months follow-up
Time frame: 6 months follow-up
The primary outcomes are biochemically validated quit rate (exhaled carbon monoxide < 4 ppm or salivary cotinine < 30 ng/ml)
6 secondary outcomes
Biochemical validated quit rate at 3 months follow-up
Time frame: 3 months follow-up
Self-reported 7-day point prevalence quit rate
Time frame: 3 and 6 months follow-up
Smoking reduction rate
Time frame: 3 and 6 months follow-up
Eligibility rate
Time frame: baseline
Consent rate
Time frame: baseline
Percentage of Participant Engagement with E-Messages and Counselor Chats
Time frame: 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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 5A's/5R's advice, Brief leaflet on health warning and smoking cessation and Self-help smoking cessation booklet in people with Smoking Cessation and Mobile Health, run by Beijing Normal University at 1 site in China.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biochemical validated quit rate at 6 months follow-up (time frame: 6 months 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 9 Sep 2026.