Smoking CessationPhase 3NCT00840242
Smoking Reduction or Cessation With Nicotine Replacement Therapy
A Phase 3 study testing Nicotine gum and Nicotine inhaler in people with Smoking Cessation, run by McNeil AB at 2 sites in Czechia.
Trial summary
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products. 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?
- Nicotine gum and Nicotine inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- 2 sitesCzechia
- Study dates
- Feb 1999to May 2000
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18
- Smoking >/= 15 cigarettes/day
- Having smoked for 3 years or more
- CO >/= 10ppm at inclusion
- Want to reduce smoking
- Prepared to adhere to the protocol
- Willing to provide signed informed consent
- Having made at least one serious attempt to quit smoking
Who cannot join
- Unstable angina pectoris, myocardial infarction within the last three months
- Use of other nicotine-containing products such as cigars, pipes, snuff
- Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
- Pregnancy/lactation or intended pregnancy
- Under psychiatric care or medication that might interfere with the trial
- Abuse of alcohol or any other drug
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Smoking Cessation Clinic
Kutná Hora, CZ-28430
Institute of Hygiene and Epidemiology
Prague, CR-12800
About this study
Official title: Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.
The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
Read the detailed description
To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction
- Conditions
- Smoking Cessation
- Being tested
- Nicotine gum, Placebo gum, Nicotine inhaler, Placebo inhaler
- Medical subject headings
- 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
8-12 pieces per day, maximum 24 daily
Placebo gumDrug
8-12 pieces per day, maximum 24 daily
Nicotine inhalerDrug
Also called Nicorette® Inhaler
6-12 cartridges per day, maximum 12 daily
Placebo inhalerDrug
6-12 cartridges per day, maximum 12 daily
| Study group | Role | What they receive |
|---|---|---|
| Nicotine gum | Experimental | Nicotine gum Receives: Drug: Nicotine gum |
| Placebo gum | Placebo comparator | Placebo gum Receives: Drug: Placebo gum |
| Nicotine inhaler | Active comparator | Nicotine inhaler Receives: Drug: Nicotine inhaler |
| Placebo inhaler | Placebo comparator | Placebo inhaler Receives: Drug: Placebo inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Measured: Baseline to 6 weeks, 3 and 4 months
Secondary outcomes (2)
Changes in laboratory values of cardiovascular risk factors
Measured: Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 1999
- Primary completionMay 2000
- Study completionMay 2000
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840242
- Sponsor's protocol ID
- 97 NITG 001
- Status last verified
- Apr 2012
- First submitted
- 9 Feb 2009
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.
- ClinicalTrials.gov ID
- NCT00840242
- Acronym / sponsor ID
- 97 NITG 001
- Conditions
- Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- May 2000 (actual)
- Study completion
- May 2000 (actual)
- First posted
- 10 Feb 2009 (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 purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.
Detailed description
To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine gum | Experimental | Drug: Nicotine gumNicotine gum |
| Placebo gum | Placebo comparator | Drug: Placebo gumPlacebo gum |
| Nicotine inhaler | Active comparator | Drug: Nicotine inhalerNicotine inhaler |
| Placebo inhaler | Placebo comparator | Drug: Placebo inhalerPlacebo inhaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above 18
- Smoking >/= 15 cigarettes/day
- Having smoked for 3 years or more
- CO >/= 10ppm at inclusion
- Want to reduce smoking
Key exclusion criteria (6 listed)
- Unstable angina pectoris, myocardial infarction within the last three months
- Use of other nicotine-containing products such as cigars, pipes, snuff
- Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
- Pregnancy/lactation or intended pregnancy
- Under psychiatric care or medication that might interfere with the trial
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® Gum8-12 pieces per day, maximum 24 daily | Drug | Nicotine gum |
| Placebo gum8-12 pieces per day, maximum 24 daily | Drug | Placebo gum |
| Nicotine inhalerAlso: Nicorette® Inhaler6-12 cartridges per day, maximum 12 daily | Drug | Nicotine inhaler |
| Placebo inhaler6-12 cartridges per day, maximum 12 daily | Drug | Placebo inhaler |
Primary outcome
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Time frame: Baseline to 6 weeks, 3 and 4 months
2 secondary outcomes
Changes in laboratory values of cardiovascular risk factors
Time frame: Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Time frame: Baseline up to 12 months
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 25 Apr 2012.
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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.
Elisabeth Kruse, PhD study director
McNeil AB
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nicotine gum and Nicotine inhaler in people with Smoking Cessation, run by McNeil AB at 2 sites in Czechia.
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 8 inclusion and 6 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 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels (time frame: Baseline to 6 weeks, 3 and 4 months). 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 25 Apr 2012; AzTrials last refreshed its copy on 30 Oct 2026.