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Trial record 29 of 2035 for:    Smoking Cessation

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

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ClinicalTrials.gov Identifier: NCT03717051
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Derek Yee-Tak Cheung, The University of Hong Kong

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 two primary outcomes include (1) the proportion of smokers who enroll in any SC service in Hong Kong within 1 month of the recruitment; and (2) 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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Nicotine replacement therapy (NRT) sampling Behavioral: Medication counseling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers to Smoking Cessation Services and Motivating Quit Attempts
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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
1-week free NRT samples (patch or gum)

Behavioral: Medication counseling
Medication counseling

Active Comparator: Control
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
Medication counseling




Primary Outcome Measures :
  1. Proportion of participants who enroll in any smoking cessation service in Hong Kong [ Time Frame: 1 month ]
    Proportion of participants who enroll in any smoking cessation service in Hong Kong

  2. Self-reported quit attempt [ Time Frame: 1 month ]
    No smoking for at least 24 hours in the past month


Secondary Outcome Measures :
  1. Proportion of participants who enroll in any smoking cessation service in Hong Kong [ Time Frame: 3 months ]
    Proportion of participants who enroll in any smoking cessation service in Hong Kong

  2. Self-reported quit attempt [ Time Frame: 3 months ]
    No smoking for at least 24 hours in the past month

  3. self-reported use of NRT in past week/month [ Time Frame: 1 month ]
    self-reported use of NRT in past week/month

  4. self-reported use of NRT in past week/month [ Time Frame: 3 months ]
    self-reported use of NRT in past week/month

  5. self-reported tobacco abstinence in past 7 days [ Time Frame: 3 months ]
    self-reported tobacco abstinence in past 7 days

  6. self-reported tobacco abstinence in past 30 days [ Time Frame: 3 months ]
    self-reported tobacco abstinence in past 30 days

  7. self-reported tobacco abstinence in past 7 days [ Time Frame: 6 months ]
    self-reported tobacco abstinence in past 7 days

  8. self-reported tobacco abstinence in past 30 days [ Time Frame: 6 months ]
    self-reported tobacco abstinence in past 30 days

  9. biochemically validated abstinence at 6-month follow-up [ Time Frame: 6 months ]
    measurement of exhaled carbon monoxide using a Smokerlyzer, and a saliva cotinine test

  10. perceived importance, difficulty and confidence to quit smoking [ Time Frame: 1 month ]

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

    Reference:

    Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.


  11. perceived importance, difficulty and confidence to quit smoking [ Time Frame: 3 months ]

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

    Reference:

    Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.


  12. perceived importance, difficulty and confidence to quit smoking [ Time Frame: 6 months ]

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

    Reference:

    Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.


  13. progression towards smoking cessation [ Time Frame: 1 month ]
    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S)

  14. progression towards smoking cessation [ Time Frame: 3 months ]
    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S)

  15. progression towards smoking cessation [ Time Frame: 6 months ]
    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717051


Contacts
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Contact: Yee Tak Derek Cheung, PhD +852 3917 6652 derekcheung@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong, 00
Contact: Yee Tak Derek Cheung, PhD    +852 3917 6652    derekcheung@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yee Tak Derek Cheung, PhD The University of Hong Kong

Publications:
Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 59: Pattern of Smoking. Hong Kong: Census & Statistics Department 2016.
Leung DYP, Chan SSC, Jiang CQ, et al. Providing Smoking Cessation Services and Its Relationship with Knowledge and Attitudes: A Comparison of the Guangzhou and Hong Kong Nurses. Journal of Comparative Asian Development 2009;8(1):179-205.
Aveyard P, Foulds J. The 2009 US Clinical Practice Guideline: the key recommendations and a commentary (www.treatobacco.net 2009 Ask the Experts). 2009 Date;Volume. http://www.treatobacco.net/fr/page_349.php (accessed 01 March 2009).

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Responsible Party: Dr. Derek Yee-Tak Cheung, Research Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03717051     History of Changes
Other Study ID Numbers: NRTsampling2018
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data and documentation will be available upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available for 10 years.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Derek Yee-Tak Cheung, The University of Hong Kong:
intervention
nicotine replacement sample
smoking cessation
smoking hotspots

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action