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

NCT03717051 | Completed Results

• 1 other identifier: NRTsampling2018
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation

Keywords

intervention; nicotine replacement sample; smoking cessation; smoking hotspots

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

  Number of participants who enroll in any smoking cessation service in Hong Kong

  1 month

• Number of Participants With Self-reported Quit Attempt

  No smoking for at least 24 hours in the past month

  1 month

Secondary Outcomes (15)

• Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

  3 months

• Number of Participants With Self-reported Quit Attempt

  3 months

• Number of Participants With Self-reported Use of NRT in Past Week/Month

  1 month

• Number of Participants With Self-reported Use of NRT in Past Week/Month

  3 months

• Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.

Drug: Nicotine replacement therapy (NRT) sampling; Behavioral: Medication counseling

Control

ACTIVE COMPARATOR

The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.

Behavioral: Medication counseling

Interventions

Nicotine replacement therapy (NRT) sampling DRUG

1-week free NRT samples (patch or gum)

Intervention

Medication counseling BEHAVIORAL

Medication counseling

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, 00, Hong Kong

Location

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  PMID: 32269028 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Derek Cheung
• Organization: University of Hong Kong

derekcheung@hku.hk

39176652

Study Officials

• Yee Tak Derek Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 12, 2018
• First Posted: October 23, 2018
• Study Start: October 13, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: May 16, 2024
• Results First Posted: July 1, 2021

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 10 years.

Locations

HK (1)