Chewing Gum for Smoking Cessation

November 22, 2025 updated by: Prof. Wang Man-Ping, The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Man Ping Wang, PhD
  • Phone Number: +852 3917 6636
  • Email: mpwang@hku.hk

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Validated abstinence
Time Frame: 6-month follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The biochemically validated smoking abstinence
Time Frame: 6-month follow-up
Smoking abstinence is defined by exhaled CO <4 ppm and salivary cotinine <30ng/ml
6-month follow-up
Number of pieces used
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
Self-reported quit attempt in the past 7 days.
2-week, 3-month, and 6-month follow-ups
Nicotine dependence level
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
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
Time Frame: 2-week, 3-month, and 6-month follow-ups
Self-reported intention to quit in the next days
2-week, 3-month, and 6-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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