Condition category
Mental and Behavioural Disorders
Date applied
08/07/2008
Date assigned
25/07/2008
Last edited
25/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lam Tai-hing

ORCID ID

Contact details

University of Hong Kong
5/F
William MW Mong Block
Li Ka Shing Faculty of Medicine Building
21 Sassoon Road
Pokfulam
Hong Kong
-
China
+852 2819 9287
hrmrlth@hkucc.hku.hk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HHSRF 01030611

Study information

Scientific title

Acronym

Smoking Reduction (SR) Project

Study hypothesis

1. The quit rate and the reduction rate are higher in the intervention groups than the control group
2. In the intervention groups, (a) the adherence rate to replacement therapy (NRT) and (b) the quit rate and the reduction rate are greater in those who have received additional adherence intervention than those who have not

Ethics approval

Institutional Review Board of the University of Hong Kong/ Hospital Authority, Hong Kong West Cluster. Date of approval: 29/05/2003 (ref: UW 03-103 T/103)

Study design

Single-centre, randomised, single-blind, placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Smokers who have no intention to quit in the near future

Intervention

Intervention group 1: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month with NRT adherence intervention

Intervention group 2: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month without NRT adherence intervention

Control: A placebo healthy diet education material and usual care provided by the hospital

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Quit rate at 6 month follow-up
2. Reduction rate at 6 month follow-up
3. Adherence rate to NRT use at 4 weeks after the first use of NRT

Secondary outcome measures

1. Validated quit rates at 6 months
2. Quit rate at 1 month without validation
3. Self-reported use of NRT continuously for at least 4 weeks or 8 weeks
4. Number of quitting attempts made by the subject. Duration of follow-up: 6 months after the baseline visit

Overall trial start date

25/10/2004

Overall trial end date

30/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age 18 or above
2. Ethnic Chinese
3. Smokes at least 2 cigarettes per day
4. Have no intention to quit in the near future
5. Intends to reduce smoking in the next 7 days
6. Has no contraindication to NRT

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

3,826

Participant exclusion criteria

1. Subjects who are psychologically or physically unable to communicate
2. Children and teenagers (age below 18)
3. Pregnant or intention to become pregnant within the next 6 months
4. 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

Recruitment start date

25/10/2004

Recruitment end date

30/07/2006

Locations

Countries of recruitment

China

Trial participating centre

University of Hong Kong
Hong Kong
-
China

Sponsor information

Organisation

Food and Health Bureau (China)

Sponsor details

Government of the Hong Kong Special Administrative Region
Secretary for Food and Health
19/F
Murray Building
Garden Road
Hong Kong
-
China
+852 21892748
enquiry@fhb.gov.hk

Sponsor type

Government

Website

http://www.fhb.gov.hk/en

Funders

Funder type

Government

Funder name

Health and Health Services Research Fund, Food and Health Bureau, Government of Hong Kong Special Administrative Region (China) (grant ref: No. 01030611)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes