The Effectiveness of Chewing Gum for Reducing Cigarette Consumption and Promoting Smoking Cessation: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The University of Hong Kong
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Validated abstinence
Study Overview
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:
- Receive very brief smoking cessation advice and booklet at baseline.
- Take chewing gum or unassisted quitting for 1 week.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Very brief smoking cessation advice (Behavioral)
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.
Intervention: Chewing gum (Behavioral)
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.
Intervention: Chewing gum usage leaflet (Behavioral)
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.
Intervention: 2-week reminder message (Behavioral)
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.
Intervention: Very brief smoking cessation advice (Behavioral)
Outcomes
Primary Outcomes
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
- Number of pieces used(2-week, 3-month, and 6-month follow-ups)
- Frequency of use(2-week, 3-month, and 6-month follow-ups)
- Duration of use(2-week, 3-month, and 6-month follow-ups)
- Health effect(2-week, 3-month, and 6-month follow-ups)
- The biochemically validated smoking abstinence(6-month follow-up)
- Self-reported 7-day point-prevalence abstinence(2-week, 3-month, and 6-month)
- Self-reported smoking change(2-week, 3-month, and 6-month follow-ups)
- Self-reported self-efficacy of quitting(2-week, 3-month, and 6-month follow-ups)
- Self-reported quit attempt(2-week, 3-month, and 6-month follow-ups)
- Nicotine dependence level(2-week, 3-month, and 6-month follow-ups)
- Smoking cessation services use(2-week, 3-month, and 6-month follow-ups)
- Self-reported intention to quit(2-week, 3-month, and 6-month follow-ups)
Investigators
Prof. Wang Man-Ping
Professor
The University of Hong Kong