Xylitol Gum for Promoting Smoking Cessation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Have communication barriers (either physical or cognitive)
Currently participating in other smoking cessation programs or services
Trial design
Design model
Parallel
Treatments tested in this trial
Brief smoking cessation advice
BehavioralBrief smoking cessation advice guided by the validated AWARD model (Assess, Warning, Advice, Refer, and Do-it-again).
Warning leaflet
BehavioralThe warning leaflet contains pictorial depictions of the adverse health effects of smoking.
Self-help smoking cessation booklet
BehavioralThe self-help smoking cessation booklet includes commonly used smoking cessation strategies.
4-week xylitol gum intervention
BehavioralParticipants 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
BehavioralThe 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
BehavioralApproximately 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.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 6 interventions
Group B: Control groupActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml
Time frame
6-month follow-upSecondary outcomes
1
Biochemically validated smoking abstinence
Verified by exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml
Time frame
3-month follow-up2
Self-report 7-day point-prevalence abstinence
By asking a question, "Have you smoked (even a puff) during the past 7 days?"
Time frame
1-, 3-, and 6-months follow-ups3
Smoking reduction
Defined by a reduction of≥50% in daily cigarette consumption compared with baseline.
Time frame
1-, 3-, and 6-months follow-ups4
Quit attempt
By asking a question, "Have you attempted to stop smoking completely for at least 24 hours in the past 7 days?"
Time frame
1-, 3-, and 6-months follow-upsOther outcomes
1
Number of pieces of xylitol gum used
Total daily count used during the intervention period
Time frame
1- and 3-month follow-ups2
Frequency of using xylitol gum
Average number of chewing episodes per day.
Time frame
1- and 3-month follow-ups3
Duration of use
Average time spent chewing each piece.
Time frame
1- and 3-month follow-upsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: