Smoking CessationNCT00563329
Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial
A study testing Reduction Intervention + Adherence Intervention and Reduction Intervention in people with Smoking Cessation, run by Hospital Authority, Hong Kong at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Reduction Intervention + Adherence Intervention and Reduction Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 3,826 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2004to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
HAHO
Hong Kong
Hong Kong Council on Smoking and Health
Hong Kong
The University of Hong Kong
Hong Kong
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- Reduction Intervention + Adherence Intervention, Reduction Intervention, control
- Keywords
- Smokers who are not willing to quit in the near future but intend to reduce smoking
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction Intervention + Adherence InterventionProcedure or surgery
Reduction InterventionBehavioural
controlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
quit rate
Measured: 6 months
Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline)
Measured: 6 months
Adherence Rate to NRT
Measured: 4 weeks
Secondary outcomes (3)
Validated quit rate (by measuring exhaled CO and urinary cotinine level)
Measured: 6 months
Quit rate without validation
Measured: 1 month
self-reported use of NRT for at least 4 weeks or 8 weeks, without cotinine validation
Measured: 1 month / 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startOct 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 3,826 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Investigators
- TH Lam, Prof, Principal investigator, Department of Community Medicine, Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563329
- Sponsor's protocol ID
- UW 03-103 T/103
- Other IDs
- HARECCTR0500051
- Status last verified
- Oct 2013
- First submitted
- 21 Nov 2007
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT00563329
- Acronym / sponsor ID
- UW 03-103 T/103
- Conditions
- Smoking Cessation
- Keywords
- Smokers who are not willing to quit in the near future but intend to reduce smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,826 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- The University of Hong Kong
- Study start
- Oct 2004
- Study completion
- Jul 2006 (actual)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction Intervention + Adherence Intervention | Procedure or surgery | – |
| Reduction Intervention | Behavioural | – |
| control | Procedure or surgery | – |
Primary outcome
quit rate
Time frame: 6 months
Reduction Rate (reduction of cigarette consumption by at least 50% compared with baseline)
Time frame: 6 months
Adherence Rate to NRT
Time frame: 4 weeks
3 secondary outcomes
Validated quit rate (by measuring exhaled CO and urinary cotinine level)
Time frame: 6 months
Quit rate without validation
Time frame: 1 month
self-reported use of NRT for at least 4 weeks or 8 weeks, without cotinine validation
Time frame: 1 month / 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TH Lam, Prof principal investigator
Department of Community Medicine, Faculty of Medicine, The University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction Intervention + Adherence Intervention and Reduction Intervention in people with Smoking Cessation, run by Hospital Authority, Hong Kong at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quit rate (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2013.