ClinicalTrials.gg
Status unknownNCT05881083QTW2023Updated Jul 11, 2023

Nicotine Replacement Therapy Sampling for Smokers in the Community

An interventional study of 1-week nicotine replacement therapy sampling and Brief cessation advice in Tobacco Smoking, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,014
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tobacco Smoking

Keywords

  • smoking
  • tobacco
  • nicotine replacement therapy
  • lay counsellor
03

In context

Tobacco Smoking

81 studies on the registry are indexed under Tobacco Smoking; 27 are open to participants now.

This study's planned enrollment of 1,014 is above the median of 120 across 69 interventional studies indexed under Tobacco Smoking.

Browse Tobacco Smoking studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,014 participants (estimated)

Study arms

  • Experimental
    Intervention group

    1-week nicotine replacement therapy sample + Brief cessation advice

    Behavioral: 1-week nicotine replacement therapy sampling · Behavioral: Brief cessation advice

  • Active comparator
    Control group

    Brief cessation advice

    Behavioral: Brief cessation advice

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

  • BehavioralBrief 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

06

What researchers measure

Primary outcomes

  1. Biochemically validated tobacco abstinence

    Verified by a negative salivary cotinine test

    Time frame: 6 months

Secondary outcomes

  1. Biochemically validated tobacco abstinence

    Verified by a negative salivary cotinine test

    Time frame: 3 months

  2. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: 3 months

  3. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: 6 months

  4. Self-reported 24-hour quit attempt

    Time frame: 3 months

  5. Self-reported 24-hour quit attempt

    Time frame: 6 months

  6. Self-reported use of nicotine replacement therapy product

    Time frame: 3 months

  7. Self-reported use of nicotine replacement therapy product

    Time frame: 6 months

  8. Self-reported use of smoking cessation service

    Time frame: 3 months

  9. Self-reported use of smoking cessation service

    Time frame: 6 months

Other outcomes

  1. Self-reported reduction of tobacco consumption

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

    Time frame: 3 months

  2. Self-reported reduction of tobacco consumption

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

    Time frame: 6 months

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

    Time frame: 3 months

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

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Community sites
    Hong Kong, Hong Kong
    • Tzu Tsun Luk · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05881083
Collaborators
Hong Kong Council on Smoking and Health
Responsible party
Tzu Tsun Luk (Research Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
May 31, 2023
Start date
Jun 17, 2023
Primary completion
May 31, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jul 11, 2023

Study contacts

Tzu Tsun Luk, PhD, RN
Contact
luktt@connect.hku.hk
+852-3917-7574
Sik Kwan Chan, PhD
Contact
kskchan@hku.hk
+852-3910-3134
Tzu Tsun Luk, PhD, RN
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion