Nicotine Replacement Therapy Sampling for Smokers in the Community

Not Applicable

Recruiting

• Conditions: Tobacco Smoking
• Interventions: Behavioral: Brief cessation advice; Behavioral: 1-week nicotine replacement therapy sampling

• Registration Number: NCT05881083
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-31
• Study Start: 2023-06-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-09
• Last Update Posted: 2023-07-11
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1014

Inclusion Criteria

1. Hong Kong residents aged 18 years or above
2. Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
3. Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
4. Able to communicate in and read Chinese
5. Have a local contact number

Exclusion Criteria

1. Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
2. Pregnant or breastfeeding
3. Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Brief cessation advice	Brief cessation advice
Intervention group	1-week nicotine replacement therapy sampling	1-week nicotine replacement therapy sample + Brief cessation advice
Intervention group	Brief cessation advice	1-week nicotine replacement therapy sample + Brief cessation advice

Primary Outcome Measures

Name	Time	Method
Biochemically validated tobacco abstinence	6 months	Verified by a negative salivary cotinine test

Secondary Outcome Measures

Name	Time	Method
Self-reported 24-hour quit attempt	6 months
Biochemically validated tobacco abstinence	3 months	Verified by a negative salivary cotinine test
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

Trial Locations

Locations (1)

Community sites; 🇭🇰 Hong Kong, Hong Kong