NCT00563329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,826

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

November 21, 2007

Last Update Submit

October 22, 2013

Conditions

Smoking Cessation

Keywords

Smokers who are not willing to quit in the near future but intend to reduce smoking

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Interventions

Reduction Intervention + Adherence InterventionPROCEDURE
Reduction InterventionBEHAVIORAL
controlPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HAHO

Hong Kong, China

Location

Hong Kong Council on Smoking and Health

Hong Kong, China

Location

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • TH Lam, Prof

    Department of Community Medicine, Faculty of Medicine, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

October 1, 2004

Study Completion

July 1, 2006

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

CN(3)