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Nicotine Replacement Therapy Sampling for Smokers in the Community

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05881083
Acronym
QTW2023
Enrollment
1014
Registered
2023-05-31
Start date
2023-06-17
Completion date
2024-06-30
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Smoking

Keywords

smoking, tobacco, nicotine replacement therapy, lay counsellor

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.

Interventions

BEHAVIORAL1-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

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

Sponsors

Hong Kong Council on Smoking and Health
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Biochemically validated tobacco abstinence6 monthsVerified by a negative salivary cotinine test

Secondary

MeasureTime frameDescription
Self-reported 7-day point-prevalence tobacco abstinence3 months
Self-reported 24-hour quit attempt3 months
Self-reported use of nicotine replacement therapy product3 months
Self-reported use of smoking cessation service3 months
Biochemically validated tobacco abstinence3 monthsVerified by a negative salivary cotinine test

Other

MeasureTime frameDescription
Change in motivation to quit from baseline through 6-month follow-up6 months
Change in motivation to quit from baseline through 3-month follow-up3 months
Self-reported reduction of tobacco consumption3 monthsSmoking reduction by at least half of the baseline daily number of cigarettes

Countries

Hong Kong

Contacts

Primary ContactTzu Tsun Luk, PhD, RN
luktt@connect.hku.hk+852-3917-7574
Backup ContactSik Kwan Chan, PhD
kskchan@hku.hk+852-3910-3134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026