QTW2023: Nicotine Replacement Therapy Sampling for Smokers in the Community

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05881083
• Collaborator: Hong Kong Council on Smoking and Health (Other)
• Enrollment: 1,014
• Arms: 2
• Anticipated Duration (Months): 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Smoking	Behavioral: 1-week nicotine replacement therapy sampling; Behavioral: Brief cessation advice	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1014 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 17, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 1-week nicotine replacement therapy sample + Brief cessation advice	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; Behavioral: 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
Active Comparator: Control group Brief cessation advice	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Biochemically validated tobacco abstinence [6 months]

   Verified by a negative salivary cotinine test

Secondary Outcome Measures

1. Biochemically validated tobacco abstinence [3 months]

   Verified by a negative salivary cotinine test

2. Self-reported 7-day point-prevalence tobacco abstinence [3 months]

3. Self-reported 7-day point-prevalence tobacco abstinence [6 months]

4. Self-reported 24-hour quit attempt [3 months]

5. Self-reported 24-hour quit attempt [6 months]

6. Self-reported use of nicotine replacement therapy product [3 months]

7. Self-reported use of nicotine replacement therapy product [6 months]

8. Self-reported use of smoking cessation service [3 months]

9. Self-reported use of smoking cessation service [6 months]

Other Outcome Measures

1. Self-reported reduction of tobacco consumption [3 months]

   Smoking reduction by at least half of the baseline daily number of cigarettes

2. Self-reported reduction of tobacco consumption [6 months]

   Smoking reduction by at least half of the baseline daily number of cigarettes

3. Change in motivation to quit from baseline through 3-month follow-up [3 months]

4. Change in motivation to quit from baseline through 6-month follow-up [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The University of Hong Kong
• Hong Kong Council on Smoking and Health

Investigators

• Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tzu Tsun Luk, Research Assistant Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT05881083
• Other Study ID Numbers: QTW2023
• First Posted: May 31, 2023
• Last Update Posted: May 31, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tzu Tsun Luk, Research Assistant Professor, The University of Hong Kong: smoking; tobacco; nicotine replacement therapy; lay counsellor
• Additional relevant MeSH terms: Nicotine

Study Results

No Results Posted as of May 31, 2023