NCT06801860

Brief Summary

The goal of this trial is to assess the feasibility, acceptability, and preliminary effectiveness of chewing gum to reduce cigarette consumption and promote smoking cessation. The main questions it aims to answer are: Do participants in the intervention group report a higher reduction in cigarette consumption, improved smoking cessation outcomes, and healthier oral health than the control group? Researchers will compare chewing gum intervention to unassisted quitting to see if chewing gum works to cigarette reduction and smoking cessation. Participants will:

  1. 1.Receive very brief smoking cessation advice and booklet at baseline.
  2. 2.Take chewing gum or unassisted quitting for 1 week.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

December 1, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 24, 2025

Last Update Submit

November 22, 2025

Conditions

Keywords

Chewing gumBehavioral interventionSmoking cessation

Outcome Measures

Primary Outcomes (1)

  • Validated abstinence

    Biochemically validated smoking abstinence will be measured by saliva cotinine level (exhaled carbon monoxide \<4 ppm and salivary cotinine \<30 ng/ml)

    6-month follow-up

Secondary Outcomes (12)

  • Number of pieces used

    2-week, 3-month, and 6-month follow-ups

  • Frequency of use

    2-week, 3-month, and 6-month follow-ups

  • Duration of use

    2-week, 3-month, and 6-month follow-ups

  • Health effect

    2-week, 3-month, and 6-month follow-ups

  • The biochemically validated smoking abstinence

    6-month follow-up

  • +7 more secondary outcomes

Study Arms (2)

Chewing gum

EXPERIMENTAL

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period. They will also receive a leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.Additionally, participants in the intervention group will receive 2-week reminder message to boost gum usage.

Behavioral: Very brief smoking cessation adviceBehavioral: Chewing gumBehavioral: Chewing gum usage leafletBehavioral: 2-week reminder message

Unassisted quitting

ACTIVE COMPARATOR

Participants in the unassisted quitting group (control group) will receive very brief smoking cessation advice (30 seconds) and a smoking cessation information booklet at baseline.

Behavioral: Very brief smoking cessation advice

Interventions

All participants will receive very brief smoking cessation advice (guided by the AWARD model, assess, warning, refer, and do-it-again) with a smoking cessation information booklet onsite at baseline.

Chewing gumUnassisted quitting
Chewing gumBEHAVIORAL

Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period.

Chewing gum

A leaflet of usage tips for chewing gum, including 1) the potential benefits of chewing gum, 2) suitable usage time and dosage, and 3) the proper disposal of used gum.

Chewing gum

A 2-week reminder message guided by the Love and Care approach will be delivered to participants twice a week (a total of four).

Chewing gum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, 999077, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

February 11, 2025

Primary Completion

September 26, 2025

Study Completion

October 30, 2025

Last Updated

December 1, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations