Tobacco DependencePhase 4NCT00749463
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
A Phase 4 study testing Nicotine Gum and Nicotine Patch in people with Tobacco Dependence, run by McNeil AB at 6 sites in China.
Trial summary
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine Gum and Nicotine Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 6 sitesChina
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy males and females, aged 18 years or older
- Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users
- Current daily smoker for at least two years
- Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes
- Be motivated to stop smoking with the help of nicotine gum or patch treatment.
- Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial
- Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes.
- Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period.
- Unstable angina pectoris or myocardial infarction during the previous 3 months.
- Pregnancy, lactation or intended pregnancy.
- Any major metabolic disease, clinically important renal, hepatic disease.
- Suspected alcohol or drug abuse.
- Participation in other clinical trials in the previous three months, or during study participation.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing ChaoYang Hospital
Beijing, Beijing Municipality, 100043
People's Hospital affiliated to Beijing University
Beijing, Beijing Municipality, 100044
No. 1 Hospital affiliated to Zhongshan University
Guangzhou, Guangdong, 510080
No. 1 Hospital affiliated to Guangzhou Medical University
Guangzhou, Guangdong, 510120
Chang Zheng Hospital
Shanghai, Shanghai Municipality, 200003
Zhong Shan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit
Read the detailed description
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine Gum, Nicotine Patch
- Keywords
- nicotine dependence, smoking cessation, NRT
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine GumDrug
Also called Nicorette® Gum
2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks
Nicotine PatchDrug
Also called Nicorette® Patch
Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Gum 2 | Experimental | Nicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks Receives: Drug: Nicotine Gum |
| Gum 4 | Experimental | Nicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks Receives: Drug: Nicotine Gum |
| Patch | Experimental | Nicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. Receives: Drug: Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Adverse Events
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
Measured: 24 Weeks
Self-Reported Smoking Reduction
Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
Measured: 24 Weeks
Smoking Abstinence
Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
Measured: 24 Weeks
Secondary outcomes (4)
Carbon Monoxide (CO)-Verified Smoking Reduction
Percentage of participants with carbon monoxide (CO)-verified reduction from baseline in number of cigarettes smoked per day (%)
Measured: Baseline to Week 24
Smoking Consumption Per Day
Number of cigarettes smoked by subjects reporting smoking since last visit - total during the day (for daily smokers)
Measured: 24 Weeks from last visit:
Smoking Consumption Per Week
Number of cigarettes smoked by subjects reporting smoking since last visit - total during the the week (for non-daily smokers)
Measured: 24 Weeks from last visit:
Point Prevalence Smoking Abstinence (PPSA)
Point Prevalence Smoking Abstinence since last visit. Point prevalence abstinence is defined as the percentage of former smokers who are not smoking at a particular point in time, typically at the time of assessment.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jackie Mao, Study chair, Shanghai Johnson & Johnson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749463
- Sponsor's protocol ID
- NICTDP4009
- Status last verified
- Jul 2012
- First submitted
- 8 Sep 2008
- Last updated
- 13 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
- ClinicalTrials.gov ID
- NCT00749463
- Acronym / sponsor ID
- NICTDP4009
- Conditions
- Tobacco Dependence
- Keywords
- nicotine dependence, smoking cessation, NRT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 1 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit
Detailed description
Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gum 2 | Experimental | Drug: Nicotine GumNicotine Gum 2 mg for subjects smoking less than 20 cigarettes per day; 2 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks |
| Gum 4 | Experimental | Drug: Nicotine GumNicotine Gum 4 mg for subjects smoking 20 or more cigarettes per day; 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks |
| Patch | Experimental | Drug: Nicotine PatchNicotine Patch; Each will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy males and females, aged 18 years or older
- Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users
- Current daily smoker for at least two years
- Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes
- Be motivated to stop smoking with the help of nicotine gum or patch treatment.
Key exclusion criteria (8 listed)
- Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes.
- Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period.
- Unstable angina pectoris or myocardial infarction during the previous 3 months.
- Pregnancy, lactation or intended pregnancy.
- Any major metabolic disease, clinically important renal, hepatic disease.
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 |
|---|---|---|
| Nicotine GumAlso: Nicorette® Gum2 mg or 4 mg for 12 week treatments and followed by 12 week off-treatment follow-up. Recommend subject to use 8-12 pieces daily for first 8 weeks and 4-6 pieces daily the next 2 weeks, then reduce to 1-3 pieces each day in last 2 weeks | Drug | Gum 2, Gum 4 |
| Nicotine PatchAlso: Nicorette® PatchEach will use 15 mg/16 h patch for the first 8 weeks, 10 mg/16 h for the following 2 weeks and 5 mg/16 h for the last 2 weeks. Then followed by 12 week off-treatment follow-up. | Drug | Patch |
Primary outcome
Treatment-Related Adverse Events
Time frame: 24 Weeks
Percentage of subjects with treatment-related adverse events by preferred term, included if the percentage in any single arm was 1% or higher
Self-Reported Smoking Reduction
Time frame: 24 Weeks
Percentage of subjects self-reporting reduction from baseline in number of cigarettes smoked per day
Smoking Abstinence
Time frame: 24 Weeks
Continuous carbon monoxide (CO)-verified Smoking Abstinence from Quit day
4 secondary outcomes
Carbon Monoxide (CO)-Verified Smoking Reduction
Time frame: Baseline to Week 24
Smoking Consumption Per Day
Time frame: 24 Weeks from last visit:
Smoking Consumption Per Week
Time frame: 24 Weeks from last visit:
Point Prevalence Smoking Abstinence (PPSA)
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jackie Mao study chair
Shanghai Johnson & Johnson Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Gum and Nicotine Patch in people with Tobacco Dependence, run by McNeil AB at 6 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 7 inclusion and 8 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 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment-Related Adverse Events (time frame: 24 Weeks). 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 13 Jul 2012.