NCT05881083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,014

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 17, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

May 19, 2023

Last Update Submit

July 9, 2023

Conditions

Tobacco Smoking

Keywords

smokingtobacconicotine replacement therapylay counsellor

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated tobacco abstinence

    Verified by a negative salivary cotinine test

    6 months

Secondary Outcomes (9)

  • Biochemically validated tobacco abstinence

    3 months

  • Self-reported 7-day point-prevalence tobacco abstinence

    3 months

  • Self-reported 7-day point-prevalence tobacco abstinence

    6 months

  • Self-reported 24-hour quit attempt

    3 months

  • Self-reported 24-hour quit attempt

    6 months

  • +4 more secondary outcomes

Other Outcomes (4)

  • Self-reported reduction of tobacco consumption

    3 months

  • Self-reported reduction of tobacco consumption

    6 months

  • Change in motivation to quit from baseline through 3-month follow-up

    3 months

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

1-week nicotine replacement therapy sample + Brief cessation advice

Behavioral: 1-week nicotine replacement therapy samplingBehavioral: Brief cessation advice

Control group

ACTIVE COMPARATOR

Brief cessation advice

Behavioral: Brief cessation advice

Interventions

1-week nicotine replacement therapy samplingBEHAVIORAL

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 group
Brief cessation adviceBEHAVIORAL

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 groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community sites

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Tobacco SmokingSmoking

Condition Hierarchy (Ancestors)

BehaviorTobacco Use

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu Tsun Luk, PhD, RN

CONTACT

+852-3917-7574luktt@connect.hku.hk

Sik Kwan Chan, PhD

CONTACT

+852-3910-3134kskchan@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 31, 2023

Study Start

June 17, 2023

Primary Completion

May 31, 2024

Study Completion

June 30, 2024

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)