Nicotine Replacement Therapy Sampling for Smokers in the Community

NCT ID: NCT05881083

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1014 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-17

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

1-week nicotine replacement therapy sample + Brief cessation advice

Group Type EXPERIMENTAL

1-week nicotine replacement therapy sampling

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Control group

Brief cessation advice

Group Type ACTIVE_COMPARATOR

Brief cessation advice

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hong Kong Council on Smoking and Health

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Tzu Tsun Luk

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tzu Tsun Luk, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Community sites

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Tzu Tsun Luk, PhD, RN

Role: CONTACT

+852-3917-7574

Sik Kwan Chan, PhD

Role: CONTACT

+852-3910-3134

Facility Contacts

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Tzu Tsun Luk

Role: primary

Other Identifiers

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QTW2023

Identifier Type: -

Identifier Source: org_study_id

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