NCT05881083RecruitingNot Applicable
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2023: a Randomised Controlled Trial of 1-week Nicotine Replacement Therapy Sampling
The University of Hong Kong1 site in 1 country1,014 target enrollmentStarted: June 17, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 1,014
- Locations
- 1
- Primary Endpoint
- Biochemically validated tobacco abstinence
Study Overview
Brief Summary
The aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Hong Kong residents aged 18 years or above
- •Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
- •Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
- •Able to communicate in and read Chinese
- •Have a local contact number
Exclusion Criteria
- •Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
- •Pregnant or breastfeeding
- •Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks
Arms & Interventions
Intervention group
Experimental
1-week nicotine replacement therapy sample + Brief cessation advice
Intervention: 1-week nicotine replacement therapy sampling (Behavioral)
Intervention group
Experimental
1-week nicotine replacement therapy sample + Brief cessation advice
Intervention: Brief cessation advice (Behavioral)
Control group
Active Comparator
Brief cessation advice
Intervention: Brief cessation advice (Behavioral)
Outcomes
Primary Outcomes
Biochemically validated tobacco abstinence
Time Frame: 6 months
Verified by a negative salivary cotinine test
Secondary Outcomes
- Biochemically validated tobacco abstinence(3 months)
- Self-reported 7-day point-prevalence tobacco abstinence(6 months)
- Self-reported use of nicotine replacement therapy product(6 months)
- Self-reported use of smoking cessation service(6 months)
- Self-reported 24-hour quit attempt(6 months)
- Self-reported 7-day point-prevalence tobacco abstinence(3 months)
- Self-reported 24-hour quit attempt(3 months)
- Self-reported use of nicotine replacement therapy product(3 months)
- Self-reported use of smoking cessation service(3 months)
Investigators
Tzu Tsun Luk
Research Assistant Professor
The University of Hong Kong
Study Sites (1)
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