Nicotine Replacement Therapy Sampling for Smokers in the Community

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Behavioral: 1-week nicotine replacement therapy sampling
* Behavioral: Brief cessation advice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>1-week nicotine replacement therapy sample + Brief cessation advice | Behavioral: 1-week nicotine replacement therapy sampling<br>* Participants will be given an 1-week sample of nicotine replacement therapy (patch or gum) with brief instructions on how to use the product<br>Behavioral: Brief cessation advice<br>* Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model: A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again<br>|
| Active Comparator: Control group<br>Brief cessation advice | Behavioral: Brief cessation advice<br>* Participants will receive brief cessation advice following the AWARD (ask, warn, advise, refer, do-it-again) model: A: Ask about the tobacco use status; W: Warn about the hazards of tobacco use; A: Advise the smokers to quit; R: Refer the smokers to cessation services; D: Do-it-again<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically validated tobacco abstinence | Verified by a negative salivary cotinine test | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically validated tobacco abstinence | Verified by a negative salivary cotinine test | 3 months | 
| Self-reported 7-day point-prevalence tobacco abstinence |  | 3 months | 
| Self-reported 7-day point-prevalence tobacco abstinence |  | 6 months | 
| Self-reported 24-hour quit attempt |  | 3 months | 
| Self-reported 24-hour quit attempt |  | 6 months | 
| Self-reported use of nicotine replacement therapy product |  | 3 months | 
| Self-reported use of nicotine replacement therapy product |  | 6 months | 
| Self-reported use of smoking cessation service |  | 3 months | 
| Self-reported use of smoking cessation service |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, tobacco, nicotine replacement therapy, lay counsellor