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Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial

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ClinicalTrials.gov Identifier: NCT00563329
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : October 23, 2013
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The aims of this study are (1) to examine the effect of smoking reduction intervention (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b) on reducing daily cigarette consumption among smokers not willing to quit smoking but want to reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher (a) adherence rate, (b) reduction rate, and (c) quit rate.

Condition or disease Intervention/treatment
Smoking Cessation Procedure: Reduction Intervention + Adherence Intervention Behavioral: Reduction Intervention Procedure: control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3826 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Official Title: Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial
Study Start Date : October 2004
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. quit rate [ Time Frame: 6 months ]
  2. Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline) [ Time Frame: 6 months ]
  3. Adherence Rate to NRT [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Validated quit rate (by measuring exhaled CO and urinary cotinine level) [ Time Frame: 6 months ]
  2. Quit rate without validation [ Time Frame: 1 month ]
  3. self-reported use of NRT for at least 4 weeks or 8 weeks, without cotinine validation [ Time Frame: 1 month / 3 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Age 18 or above
  • Ethnic Chinese male or female
  • Smokes at least 2 cigarettes per day
  • Have no intention to quit in the near future
  • Intends to reduce smoking in the next 7 days
  • Has no contraindication to NRT

Exclusion Criteria:

  • Subjects who are psychologically or physically unable to communicate
  • Children and teenagers (age below 18)
  • Pregnant or intention to become pregnant within the next 6 months
  • Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions
Contacts and Locations

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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): NCT00563329


Locations
China
HAHO
Hong Kong, China
Hong Kong Council on Smoking and Health
Hong Kong, China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
The University of Hong Kong
Investigators
Principal Investigator: TH Lam, Prof Department of Community Medicine, Faculty of Medicine, The University of Hong Kong
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00563329     History of Changes
Other Study ID Numbers: UW 03-103 T/103
HARECCTR0500051
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Hospital Authority, Hong Kong:
Smokers who are not willing to quit in the near future but intend to reduce smoking