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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: 1-week nicotine replacement therapy sampling; Behavioral: Brief cessation advice

• Study Type: Interventional
• Enrollment (Estimated): 1014
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzu Tsun Luk, PhD, RN; Phone Number: +852-3917-7574; Email: luktt@connect.hku.hk
• Study Contact Backup: Name: Sik Kwan Chan, PhD; Phone Number: +852-3910-3134; Email: kskchan@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Community Sites
    • Contact: Tzu Tsun Luk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 1-week nicotine replacement therapy sample + Brief cessation advice	Behavioral: 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; 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
Active Comparator: Control group; Brief cessation advice	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated tobacco abstinence	Verified by a negative salivary cotinine test	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated tobacco abstinence	Verified by a negative salivary cotinine test	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
Self-reported use of nicotine replacement therapy product		3 months
Self-reported use of nicotine replacement therapy product		6 months
Self-reported use of smoking cessation service		3 months
Self-reported use of smoking cessation service		6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	3 months
Self-reported reduction of tobacco consumption	Smoking reduction by at least half of the baseline daily number of cigarettes	6 months
Change in motivation to quit from baseline through 3-month follow-up		3 months
Change in motivation to quit from baseline through 6-month follow-up		6 months

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hong Kong Council on Smoking and Health
• Investigators: Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: smoking; tobacco; nicotine replacement therapy; lay counsellor
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: QTW2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No