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Completed

NCT Number: NCT06801860

Chewing Gum for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The University of Hong Kong

Hong Kong, Pokfulam, 999077

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Very brief smoking cessation advice

Behavioral

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 Gum

Behavioral

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

Chewing gum usage leaflet

Behavioral

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.

2-week reminder message

Behavioral

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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. 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?"

  3. 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?"

  4. 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?"

  5. 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. 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.

  7. 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

  8. 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.

  9. Self-reported quit attempt

    Time frame: 2-week, 3-month, and 6-month follow-ups

    Self-reported quit attempt in the past 7 days.

  10. 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.

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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