N/A Completed N=834 Randomized Single-blind Treatment

Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers

Smoking Cessation

Source: ClinicalTrials.gov NCT03717051 ↗

Enrolled (actual)

834

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcomePrimary: Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong — 156; 158 Participants

Summary

Background More than 60% of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. About 30.8% of daily smokers attempted to quit but failed. Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal symptoms during early stage of tobacco abstinence and increase quit rate. However, the prevalence of using NRT in Hong Kong is lower than most of the developed countries. The proposed project aims to test if providing free NRT sampling to smokers can increase quit attempt, the use of smoking cessation (SC) services and abstinence. Methods University undergraduate students will be trained, and will invite smokers at outdoor smoking hotspots to quit smoking and enroll into SC services. Eligible smokers will be randomized to experimental or control group according to a cluster randomization, using recruitment session as the randomization unit. The experimental group will be provided with 1-week free NRT sampling and medication counselling, whereas the control group will be provided medication counselling. Both groups are advised to enroll in the SC services. The primary outcome is the proportion of smokers who report quit attempts at 1 month follow-up Discussions The findings will inform the feasibility and effectiveness of delivering free NRT sampling to increase quit attempt, the use of smoking cessation services and abstinence. It will yield more information on smokers' adherence to the NRT sampling, side effect and safety issue of the usage.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong	247; 213	—
PRIMARY Number of Participants With Self-reported Quit Attempt	300; 243	—
SECONDARY Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong	247; 213	—
SECONDARY Number of Participants With Self-reported Quit Attempt	300; 243	—
SECONDARY Number of Participants With Self-reported Use of NRT in Past Week/Month	92; 86	—
SECONDARY Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days	104; 92	—
SECONDARY Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days	93; 77	—
SECONDARY Biochemically Validated Abstinence at 6-month Follow-up	22; 10	—
SECONDARY Perceived Importance, Difficulty and Confidence to Quit Smoking	7.36; 8.09; 7.53; 7.22; 6.02; 6.47	—
SECONDARY Progression Towards Smoking Cessation	13.94; 14.58	—

Eligibility Criteria

Inclusion Criteria

Hong Kong residents
aged 18 to 65 years
have used any tobacco products in the past month
able to read and speak Chinese
have not used NRT for the past month

Exclusion Criteria

Have severe angina, serious cardiac arrhythmias and hypertension
Have suffered from acute myocardial event in the past 4 weeks
Pregnant nor breastfeeding
Under medication and treatment due to mental illness

One of the inclusion criteria was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the inclusion criteria does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking

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Data sourced from ClinicalTrials.gov (NCT03717051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.