Nicotine Replacement Therapy Sampling for Smokers in the Community

Tobacco Smoking Clinical Trial

— QTW2023  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881083
• Other study ID #: QTW2023
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: The University of Hong Kong
• Contact: Tzu Tsun Luk, PhD, RN
• Phone: +852-3917-7574
• Email: luktt[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1014
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• 1-week nicotine replacement therapy sampling
Participants will be given an 1-week sample of nicotine replacement therapy (patch or gum) with brief instructions on how to use the product
• Brief cessation advice
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

Locations

Country	Name	City	State
Hong Kong	Community sites	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Council on Smoking and Health

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	3 months
Other	Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	6 months
Other	Change in motivation to quit from baseline through 3-month follow-up		3 months
Other	Change in motivation to quit from baseline through 6-month follow-up		6 months
Primary	Biochemically validated tobacco abstinence	Verified by a negative salivary cotinine test	6 months
Secondary	Biochemically validated tobacco abstinence	Verified by a negative salivary cotinine test	3 months
Secondary	Self-reported 7-day point-prevalence tobacco abstinence		3 months
Secondary	Self-reported 7-day point-prevalence tobacco abstinence		6 months
Secondary	Self-reported 24-hour quit attempt		3 months
Secondary	Self-reported 24-hour quit attempt		6 months
Secondary	Self-reported use of nicotine replacement therapy product		3 months
Secondary	Self-reported use of nicotine replacement therapy product		6 months
Secondary	Self-reported use of smoking cessation service		3 months
Secondary	Self-reported use of smoking cessation service		6 months