Clinical trial NCT06801860: Chewing Gum for Smoking Cessation
Official title: The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Chewing gum
Behavioral intervention
Smoking cessation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Validated abstinence
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Number of pieces used
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Frequency of use
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Duration of use
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Health effect
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: The biochemically validated smoking abstinence
timeFrame: 6-month follow-up
measure: Self-reported 7-day point-prevalence abstinence
timeFrame: 2-week, 3-month, and 6-month
measure: Self-reported smoking change
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Self-reported self-efficacy of quitting
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Self-reported quit attempt
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Nicotine dependence level
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Smoking cessation services use
timeFrame: 2-week, 3-month, and 6-month follow-ups
measure: Self-reported intention to quit
timeFrame: 2-week, 3-month, and 6-month follow-ups
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
state: Pokfulam
Study officials:
References: