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Trial record 1 of 1 for:    19509277 [PUBMED-IDS]
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Motivating Smokers at Outdoor Public Smoking Hotspots to Have Quit Attempt With Nicotine Replacement Therapy Sampling

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ClinicalTrials.gov Identifier: NCT02491086
Recruitment Status : Completed
First Posted : July 7, 2015
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Derek Yee-Tak Cheung, The University of Hong Kong

Brief Summary:

Background About half of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. 37.9% 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 and hence quit successfully.

Methods Nurses and university undergraduate students will be trained, and will invite smokers at outdoor public places to participate in the randomized controlled trial, which randomized eligible smokers to intervention or control group. The intervention group will be provided with 1-week free NRT sampling and medication counselling, whereas the control group will only be advised to purchase NRT on their own. The primary outcome is the proportion of any self-reported quit attempt (no smoking for at least 24 hours) in the past month at 1- and 3-month telephone follow-up.

Discussions The findings will inform the feasibility and effectiveness of delivering free NRT sampling to increase quit attempt and abstinence. It will yield more information on smokers' adherence to the NRT sampling, side effect and safety issue of the usage. Moreover, it will guide a future larger trial to test the effect from the NRT sampling and translation to practice.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Motivating Smokers at Outdoor Public Smoking Hotspots to Have Quit Attempt With Nicotine Replacement Therapy Sampling: A Randomized Controlled Trial
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
The intervention group will receive a free pack of one-week NRT. The nurse will help the subject to decide which NRT product (patch, gum and lozenge) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption, followed by the delivery of the sampling, instructions of using the NRT sampling, an education card about NRT and a 12-page smoking cessation booklet (Figure 1). Based on the experience in the previous trials, the choice of NRT (either patch, lozenge or gum) will be made according to subject's preference, and the counsellors will provide medication counselling [25-27]. If the subject is willing to continue the counselling at recruitment, the ambassador will further introduce the NRT's side effects, adherence and effectiveness (Table 1). Otherwise, the ambassador will contact the subject for providing these details and enquiring the usage through telephone within 2 days.
Drug: Nicotine replacement therapy (NRT) sampling
1-week free NRT

Behavioral: Smoking cessation counseling
Smoking cessation counseling

Active Comparator: Control
The control group subjects will only be advised by the ambassador to purchase the NRT on their own, but will not be given the sampling. The same education card and the 12-page smoking cessation booklet will be provided.
Behavioral: Smoking cessation counseling
Smoking cessation counseling




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


Secondary Outcome Measures :
  1. Self-reported 7-day prevalence of tobacco abstinence [ Time Frame: 1 month ]
  2. Proportion of participants using NRT in the past month [ Time Frame: 1 month ]
  3. Biochemically validated quit rate, measurement of exhaled carbon monoxide [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Aged 18 years or above;
  2. Smoke 10 cigarettes or more per day in the past week;
  3. Able to read and speak Chinese;
  4. Have not used NRT for the past 3 months

Exclusion criteria:

  1. Have severe angina and serious cardiac arrhythmias;
  2. Have suffered from acute myocardial event in the past 4 weeks;
  3. Pregnant and breastfeeding

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): NCT02491086


Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong, 00
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Yee Tak Derek Cheung, Cheung The University of Hong Kong

Publications:
Census & Statistics Department (Hong Kong SAR government): Thematic Household Survey, Report No. 53: Pattern of Smoking. In. Hong Kong: Census & Statistics Department; 2013
Hong Kong Council on Smoking and Health: June 2013, COSH Report No. 16 - Quit to Win 2010 and smoking cessation. In. Hong Kong: Hong Kong Council on Smoking Health; 2013.
National Institue for Clinical Excellence: Guidance on the use of nicotine replacement therapy (NRT) and bupropion for smoking cessation. In. NHS, London: National Institue for Clinical Excellence; 2002.
Medline Plus: Nicotine Replacement Therapy. In: Nicotine Replacement Therapy: MedlinePlus Medical Encyclopedia U.S.: U.S. National Library of Medicine, National Insititutes of Health; 2009.
World Health Organization: Adherence to long-term therapies: Evidence for action. In. Geneva: World Health Organization; 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Derek Yee-Tak Cheung, Post-doctoral Fellow, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02491086     History of Changes
Other Study ID Numbers: 201409176211
First Posted: July 7, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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