Xylitol Gum for Promoting Smoking Cessation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Health Promotion
• Intervention / Treatment: Behavioral: Brief smoking cessation advice; Behavioral: Warning leaflet; Behavioral: Self-help smoking cessation booklet; Behavioral: 4-week xylitol gum intervention; Behavioral: Instructional leaflet; Behavioral: 12-week instant message support

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man Ping Wang, PhD; Phone Number: +852 3917 6636; Email: mpwang@hku.hk
• Study Contact Backup: Name: Mengyao Li, Mphil; Phone Number: +852 6851 8462; Email: lmy0814@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • School of Nursing, The University of Hong Kong
    • Contact: Mengyao Li; Phone Number: 68518462; Email: lmy0814@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants assigned to 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.	Behavioral: Brief smoking cessation advice; Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).; Behavioral: Warning leaflet; The warning leaflet contains pictorial depictions of the adverse health effects of smoking.; Behavioral: Self-help smoking cessation booklet; The self-help smoking cessation booklet includes commonly used smoking cessation strategies.; Behavioral: 4-week xylitol gum intervention; 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.; Behavioral: Instructional leaflet; 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.; Behavioral: 12-week instant message support; 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.
Active Comparator: Control group; Participants in the control group will receive brief SC advice and a SC information booklet at baseline, which had been routinely used in our previous trials.	Behavioral: Brief smoking cessation advice; Brief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).; Behavioral: Warning leaflet; The warning leaflet contains pictorial depictions of the adverse health effects of smoking.; Behavioral: Self-help smoking cessation booklet; The self-help smoking cessation booklet includes commonly used smoking cessation strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated smoking abstinence	Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml	6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated smoking abstinence	Verified by exhaled carbon monoxide <4 ppm and salivary cotinine <30 ng/ml	3-month follow-up
Self-report 7-day point-prevalence abstinence	By asking a question, "Have you smoked (even a puff) during the past 7 days?"	1-, 3-, and 6-months follow-ups
Smoking reduction	Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.	1-, 3-, and 6-months follow-ups
Quit attempt	By asking a question, "Have you attempted to stop smoking completely for at least 24 hours in the past 7 days?"	1-, 3-, and 6-months follow-ups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pieces of xylitol gum used	Total daily count used during the intervention period	1- and 3-month follow-ups
Frequency of using xylitol gum	Average number of chewing episodes per day.	1- and 3-month follow-ups
Duration of use	Average time spent chewing each piece.	1- and 3-month follow-ups

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Man Ping Wang, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Smoking cessation; Xylitol gum; Hybrid type 1 effectiveness-implementation design
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation
• Other Study ID Numbers: Chew 2 quit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No