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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Procedure: control; Procedure: Reduction Intervention + Adherence Intervention; Behavioral: Reduction Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 3826
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • The University of Hong Kong
  • Hong Kong, China
    • HAHO
  • Hong Kong, China
    • Hong Kong Council on Smoking and Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
quit rate	6 months
Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline)	6 months
Adherence Rate to NRT	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• Collaborators: The University of Hong Kong
• Investigators: Principal Investigator: TH Lam, Prof, Department of Community Medicine, Faculty of Medicine, The University of Hong Kong

Publications and helpful links

Helpful Links

• HAREC Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 23, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Smokers who are not willing to quit in the near future but intend to reduce smoking
• Other Study ID Numbers: UW 03-103 T/103; HARECCTR0500051