Chewing Gum for Smoking Cessation

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

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

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Very brief smoking cessation advice; Behavioral: Chewing gum; Behavioral: Chewing gum usage leaflet; Behavioral: 2-week reminder message

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Pokfulam
    • Hong Kong, Pokfulam, Hong Kong, 999077
      • School of Nursing, The University of Hong Kong

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Having communication barriers (either physical or cognitive)
2. 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
Active Comparator: Unassisted quitting; 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; 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.
Experimental: Chewing gum; 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 advice; 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.; Behavioral: Chewing gum; Participants in the intervention group will receive 1-2 packs of chewing gum over a 1-week intervention period.; Behavioral: Chewing gum usage leaflet; 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.; Behavioral: 2-week reminder message; A 2-week reminder message guided by the Love and Care approach will be delivered to participants twice a week (a total of four).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The biochemically validated smoking abstinence	Smoking abstinence is defined by exhaled CO <4 ppm and salivary cotinine <30ng/ml	6-month follow-up
Number of pieces used	The number of pieces used will be measured by a self-designed question: "On average, how many pieces of gum do you use every day?"	2-week, 3-month, and 6-month follow-ups
Frequency of use	The frequency of use will be measured by a self-designed question: "In the past seven days, how many days have you used chewing gum?"	2-week, 3-month, and 6-month follow-ups
Duration of use	Duration of use will be measured by a self-designed question: "How long do you typically use it at a time?"	2-week, 3-month, and 6-month follow-ups
Health effect	Health effect will be measured by a self-designed question: "Have you noticed any changes in your oral health after using chewing gum?"	2-week, 3-month, and 6-month follow-ups
Self-reported 7-day point-prevalence abstinence	Smokers who did not smoke even a puff in the 7 days preceding the follow-up.	2-week, 3-month, and 6-month
Self-reported smoking change	Self-reported change in number of cigarettes smoked daily of at least less 50% of the baseline number	2-week, 3-month, and 6-month follow-ups
Self-reported self-efficacy of quitting	Self-reported self-efficacy of quitting includes the perception of quitting importance, difficulty, and confidence, assessing by an item scaled with 0-10, respectively. The score of zero refers to very unimportant, very easy, or very unconfident. The score of 10 refers to very important, very difficult, or very confident, respectively. Higher score refers to higher perception of quitting importance, difficulty, and confidence.	2-week, 3-month, and 6-month follow-ups
Self-reported quit attempt	Self-reported quit attempt in the past 7 days.	2-week, 3-month, and 6-month follow-ups
Nicotine dependence level	The nicotine dependence level will be measured by the Fagerstrom Test for Nicotine Dependence (FTND). The score ranges from 0 to 10, with higher scores indicating greater nicotine dependence.	2-week, 3-month, and 6-month follow-ups
Smoking cessation services use	Using the smoking cessation service from hospitals or the government in Hong Kong	2-week, 3-month, and 6-month follow-ups
Self-reported intention to quit	Self-reported intention to quit in the next days	2-week, 3-month, and 6-month follow-ups

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Smoking cessation; Chewing gum; Behavioral intervention
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Biological Products; Complex Mixtures; Biopolymers; Plant Gums; Plant Exudates; Candy; Chewing Gum
• Other Study ID Numbers: Chew-to-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
• product manufactured in and exported from the U.S.: No