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NCT Number: NCT07240545

Xylitol Gum for Promoting Smoking Cessation

The goal of this clinical trial is to learn if 4-week xylitol gum intervention works to promote smoking cessation in daily smokers. It will also learn about the feasibility and acceptability of using xylitol gum. The main questions it aims to answer are:

(1)Does xylitol gum help to reduce cigarette consumption and promote smoking cessation?

Researchers will compare 4-week xylitol gum intervention to the brief advice to see if xylitol gum works to promote smoking cessation.

Participants in the intervention group will receive a 3-month behavioral intervention comprising a 4-week xylitol gum aligned with 12 weeks of instant reminder message support.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a proactive smoking cessation intervention using xylitol chewing gum. Eligible participants will be Hong Kong residents aged ≥18 years who (1) have smoked at least one cigarette per day in the past 3 months; (2) can communicate in Cantonese (including reading Chinese); (3) express an intention to quit or reduce smoking; (4) are able to use instant messaging tools (e.g., WhatsApp); and (5) regularly chew gum or are willing to use chewing gum for smoking reduction.

A total of 134 participants will be recruited from community settings, including public housing estates across Hong Kong's 18 districts, community and university smoking hotspots, referrals from other smoking cessation programmes, and social media promotions (Facebook and Instagram). The study will adopt a hybrid type I effectiveness-implementation design. Participants will be followed up at 1, 3, and 6 months post-enrolment via telephone, following CONSORT guidelines, to assess cigarette reduction and cessation outcomes.

All participants will receive brief smoking cessation advice at baseline using the AWARD model (Ask/Assess, Warn, Advise, Refer, and Do-it-again), accompanied by a health warning leaflet and a smoking cessation information booklet.

Interventions are as follows:

Chewing gum group (intervention): Participants will receive 4 packs of xylitol gum at baseline and up to 24 packs throughout the 12-week intervention. Approximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered via instant messaging to reinforce motivation and adherence.

Unassisted quitting group (control): Participants will receive brief advice only at baseline.

To explore user experience and acceptability, semi-structured qualitative interviews will be conducted with 20 intervention-group participants to understand their perceptions and experiences with xylitol gum use.

The primary outcome is biochemically validated smoking abstinence at 6 months, defined as exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/mL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Residents of Hong Kong aged 18 or above who smoke at least 1 cigarette per day over the past 3 months
  • Have the habit of chewing gum or are willing to use chewing gum
  • Can communicate in Cantonese (including reading Chinese)
  • Express an intention to quit or reduce smoking
  • Capable of using instant messaging tools (e.g., WhatsApp, WeChat) for communication

Exclusion criteria

  • Have communication barriers (either physical or cognitive)
  • Currently participating in other smoking cessation programs or services

Treatment and study plan

Brief smoking cessation advice

Behavioral

Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).

Warning leaflet

Behavioral

The warning leaflet contains pictorial depictions of the adverse health effects of smoking.

Self-help smoking cessation booklet

Behavioral

The self-help smoking cessation booklet includes commonly used smoking cessation strategies.

4-week xylitol gum intervention

Behavioral

Participants in the intervention group will receive 4 packs of xylitol gum (approximately US $2 per pack) at baseline and will be encouraged to use it when they experience cravings.

Instructional leaflet

Behavioral

The instructional leaflet includes the potential benefits of xylitol gum for smoking cessation, recommended timing and dosage for use, and appropriate disposal of used gum.

12-week instant message support

Behavioral

Approximately 24 reminder messages (two per week), developed based on the Love and Care Approach framework, will be delivered over the 12-week period to reinforce motivation and adherence.

Primary outcomes

  1. Biochemically validated smoking abstinence

    Time frame: 6-month follow-up

    Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml

Secondary outcomes

  1. Biochemically validated smoking abstinence

    Time frame: 3-month follow-up

    Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml

  2. Self-report 7-day point-prevalence abstinence

    Time frame: 1-, 3-, and 6-months follow-ups

    By asking a question, "Have you smoked (even a puff) during the past 7 days?"

  3. Smoking reduction

    Time frame: 1-, 3-, and 6-months follow-ups

    Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.

  4. Quit attempt

    Time frame: 1-, 3-, and 6-months follow-ups

    By asking a question, "Have you attempted to stop smoking completely for at least 24 hours in the past 7 days?"

Other outcomes

  1. Number of pieces of xylitol gum used

    Time frame: 1- and 3-month follow-ups

    Total daily count used during the intervention period

  2. Frequency of using xylitol gum

    Time frame: 1- and 3-month follow-ups

    Average number of chewing episodes per day.

  3. Duration of use

    Time frame: 1- and 3-month follow-ups

    Average time spent chewing each piece.

Study contacts

Contact information is provided by the study sponsor or research team.

Man Ping Wang, PhD

CONTACT

[email protected]

+852 3917 6636

Mengyao Li, Mphil

CONTACT

[email protected]

+852 6851 8462

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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