Chewing Gum for Smoking Cessation

Not Applicable

Recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT06801860
• Lead Sponsor: The University of Hong Kong

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. Receive very brief smoking cessation advice and booklet at baseline.

2. Take chewing gum or unassisted quitting for 1 week.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study Start: 2025-02-11
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-08-26
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Validated abstinence	3-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 Outcome Measures

Name	Time	Method
Health effect	1-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?"
The biochemically validated smoking abstinence	6-month follow-up	Smoking abstinence is defined by exhaled CO \<4 ppm and salivary cotinine \<30ng/ml
Number of pieces used	1-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?"
Frequency of use	1-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?"
Duration of use	1-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?"
Self-reported 7-day point-prevalence abstinence	1-week, 3-month, and 6-month	Smokers who did not smoke even a puff in the 7 days preceding the follow-up.
Self-reported smoking change	1-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
Self-reported self-efficacy of quitting	1-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.
Self-reported quit attempt	1-week, 3-month, and 6-month follow-ups	Self-reported quit attempt in the past 7 days.
Nicotine dependence level	1-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.
Smoking cessation services use	1-week, 3-month, and 6-month follow-ups	Using the smoking cessation service from hospitals or the government in Hong Kong
Self-reported intention to quit	1-week, 3-month, and 6-month follow-ups	Self-reported intention to quit in the next days

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Pokfulam, Hong Kong