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Nicotine Replacement Therapy Sampling for Smokers in the Community (QTW2023)

Primary Purpose

Tobacco Smoking

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
1-week nicotine replacement therapy sampling
Brief cessation advice
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Smoking focused on measuring smoking, tobacco, nicotine replacement therapy, lay counsellor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Community sitesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

1-week nicotine replacement therapy sample + Brief cessation advice

Brief cessation advice

Outcomes

Primary Outcome Measures

Biochemically validated tobacco abstinence
Verified by a negative salivary cotinine test

Secondary Outcome Measures

Biochemically validated tobacco abstinence
Verified by a negative salivary cotinine test
Self-reported 7-day point-prevalence tobacco abstinence
Self-reported 7-day point-prevalence tobacco abstinence
Self-reported 24-hour quit attempt
Self-reported 24-hour quit attempt
Self-reported use of nicotine replacement therapy product
Self-reported use of nicotine replacement therapy product
Self-reported use of smoking cessation service
Self-reported use of smoking cessation service

Full Information

First Posted
May 19, 2023
Last Updated
July 9, 2023
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Council on Smoking and Health
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1. Study Identification

Unique Protocol Identification Number
NCT05881083
Brief Title
Nicotine Replacement Therapy Sampling for Smokers in the Community
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Council on Smoking and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking
Keywords
smoking, tobacco, nicotine replacement therapy, lay counsellor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1014 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
1-week nicotine replacement therapy sample + Brief cessation advice
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Brief cessation advice
Intervention Type
Behavioral
Intervention Name(s)
1-week nicotine replacement therapy sampling
Intervention Description
Participants will be given an 1-week sample of nicotine replacement therapy (patch or gum) with brief instructions on how to use the product
Intervention Type
Behavioral
Intervention Name(s)
Brief cessation advice
Intervention Description
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
Primary Outcome Measure Information:
Title
Biochemically validated tobacco abstinence
Description
Verified by a negative salivary cotinine test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Biochemically validated tobacco abstinence
Description
Verified by a negative salivary cotinine test
Time Frame
3 months
Title
Self-reported 7-day point-prevalence tobacco abstinence
Time Frame
3 months
Title
Self-reported 7-day point-prevalence tobacco abstinence
Time Frame
6 months
Title
Self-reported 24-hour quit attempt
Time Frame
3 months
Title
Self-reported 24-hour quit attempt
Time Frame
6 months
Title
Self-reported use of nicotine replacement therapy product
Time Frame
3 months
Title
Self-reported use of nicotine replacement therapy product
Time Frame
6 months
Title
Self-reported use of smoking cessation service
Time Frame
3 months
Title
Self-reported use of smoking cessation service
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Self-reported reduction of tobacco consumption
Description
Smoking reduction by at least half of the baseline daily number of cigarettes
Time Frame
3 months
Title
Self-reported reduction of tobacco consumption
Description
Smoking reduction by at least half of the baseline daily number of cigarettes
Time Frame
6 months
Title
Change in motivation to quit from baseline through 3-month follow-up
Time Frame
3 months
Title
Change in motivation to quit from baseline through 6-month follow-up
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tzu Tsun Luk, PhD, RN
Phone
+852-3917-7574
Email
luktt@connect.hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Sik Kwan Chan, PhD
Phone
+852-3910-3134
Email
kskchan@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu Tsun Luk, PhD, RN
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community sites
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tzu Tsun Luk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nicotine Replacement Therapy Sampling for Smokers in the Community

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