ClinicalTrials.gg
Active, not recruitingNCT06570070Updated Sep 9, 2026

AI-powered Smoking Cessation Intervention

An interventional study of 5A's/5R's advice and Brief leaflet on health warning and smoking cessation in Smoking Cessation and Mobile Health, sponsored by Beijing Normal University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Beijing Normal University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Smoking Cessation
  • Mobile Health

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03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's planned enrollment of 420 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Beijing Normal University is the lead sponsor of 31 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. aged 18 and above, reside in Zhuhai for the next 6 months;
  2. smoke at least 1 cigarette or use e-cigarettes daily;
  3. Having a smartphone and a WeChat account, being able to use WeChat skillfully.

Exclusion criteria

Exclusion Criteria:

  1. Smokers who have communication barrier (either physically or cognitively);
  2. Smokers who are currently participating in other SC programmes or services
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    AI support group

    AI-powered chatbot support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet

    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

  • Experimental
    Counselor support group

    Counselor individual support+ 5A's/5R's advice + health warning leaflet+ Self-help booklet

    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

  • Active comparator
    Control group

    5A's/5R's advice + health warning leaflet+ Self-help booklet

    Behavioral: 5A's/5R's advice · Other: Brief leaflet on health warning and smoking cessation · Other: Self-help smoking cessation booklet

Interventions

  • Behavioral5A's/5R's advice

    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.

  • OtherBrief leaflet on health warning and smoking cessation

    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.

  • OtherSelf-help smoking cessation booklet

    The contents include information about the benefits of quitting, methods to quit, how to handle withdrawal symptoms, misperceptions of quitting, etc.

  • BehavioralAI-powered chatbot support

    Participants will receive three months of AI-powered chatbot, equipped with personalized interactions and real-time support, via WeChat.

  • BehavioralCounselor individual support

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months follow-up

Secondary outcomes

  1. Biochemical validated quit rate at 3 months follow-up

    biochemically validated quit rate (exhaled carbon monoxide \< 4 ppm or salivary cotinine \< 30 ng/ml)

    Time frame: 3 months follow-up

  2. Self-reported 7-day point prevalence quit rate

    Self-reported 7-day point prevalence quit rate in the two groups

    Time frame: 3 and 6 months follow-up

  3. Smoking reduction rate

    Rate of smoking reduction by at least half of baseline amount in the two groups

    Time frame: 3 and 6 months follow-up

  4. Eligibility rate

    the percentage of eligible smokers out of the total number of smokers screened

    Time frame: baseline

  5. Consent rate

    the percentage of eligible smokers who agree to participate out of the total number of eligible smokers

    Time frame: baseline

  6. 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.

    Time frame: 3 months follow-up

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06570070
Lead sponsor
Beijing Normal University
Responsible party
Sponsor
First posted
Aug 26, 2024
Start date
Jan 22, 2025
Primary completion
Aug 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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