Tobacco DependenceNCT01084707
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
A study testing Oral Nicotine, Nicotine Lozenge and Nicotine gum in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
Trial summary
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Oral Nicotine, Nicotine Lozenge and Nicotine gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Apr 2009
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Who cannot join
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
- Prior regular use of nicotine mouth spray
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
Read the detailed description
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
- Conditions
- Tobacco Dependence
- Being tested
- Oral Nicotine, Nicotine Lozenge, Nicotine gum
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- 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.
Oral NicotineDrug
Also called generic Nicotine
Oral Nicotine either self-administered or provided by study personnel within 12 hours
Nicotine LozengeDrug
Also called NiQuitin™
Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
Nicotine gumDrug
Also called Nicorette®
Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Oral Nicotine 24-SA | Experimental | 2 Self-administrations of Experimental Nicotine once every hour Receives: Drug: Oral Nicotine |
| Oral Nicotine 24 | Experimental | 2 administrations of Experimental Nicotine by study personnel once every hour Receives: Drug: Oral Nicotine |
| Oral Nicotine 48 | Experimental | 2 administrations of Experimental Nicotine by study personnel once every 30 minutes Receives: Drug: Oral Nicotine |
| NiQuitin™ Lozenge 4 mg | Active comparator | 1 NiQuitin™ lozenge, administered by study personnel once every hour Receives: Drug: Nicotine Lozenge |
| Nicorette® Gum 4 mg | Active comparator | 1 piece Nicorette® gum, chewed for 30 minutes once every hour Receives: Drug: Nicotine gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Measured: During the last dosing interval (hour 11-12 post-dose)
Average Concentration
Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
Measured: During the last dosing interval (hour 11-12 post-dose)
Secondary outcomes (4)
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Measured: During the last dosing interval (hour 11-12 post-dose)
Minimum Plasma Concentration
The minimum nicotine plasma concentration during the last dosing interval (Cmin)
Measured: During the last dosing interval (hour 11-12 post-dose)
Peak-Trough Fluctuation
Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)
Measured: During the last dosing interval (hour 11-12 post-dose)
Nicotine Plasma Concentration
The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment
Measured: One hour after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionApr 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT01084707
- Sponsor's protocol ID
- NICTDP1066-A6431117
- Other IDs
- 2008-006279-65, 2008
- Status last verified
- Jul 2012
- First submitted
- 9 Mar 2010
- 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
- Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.
- ClinicalTrials.gov ID
- NCT01084707
- Acronym / sponsor ID
- NICTDP1066-A6431117
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 19 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
Detailed description
This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Nicotine 24-SA | Experimental | Drug: Oral Nicotine2 Self-administrations of Experimental Nicotine once every hour |
| Oral Nicotine 24 | Experimental | Drug: Oral Nicotine2 administrations of Experimental Nicotine by study personnel once every hour |
| Oral Nicotine 48 | Experimental | Drug: Oral Nicotine2 administrations of Experimental Nicotine by study personnel once every 30 minutes |
| NiQuitin™ Lozenge 4 mg | Active comparator | Drug: Nicotine Lozenge1 NiQuitin™ lozenge, administered by study personnel once every hour |
| Nicorette® Gum 4 mg | Active comparator | Drug: Nicotine gum1 piece Nicorette® gum, chewed for 30 minutes once every hour |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
- Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
- A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (3 listed)
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
- Prior regular use of nicotine mouth spray
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 |
|---|---|---|
| Oral NicotineAlso: generic NicotineOral Nicotine either self-administered or provided by study personnel within 12 hours | Drug | Oral Nicotine 24, Oral Nicotine 24-SA, Oral Nicotine 48 |
| Nicotine LozengeAlso: NiQuitin™Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours | Drug | NiQuitin™ Lozenge 4 mg |
| Nicotine gumAlso: Nicorette®Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours | Drug | Nicorette® Gum 4 mg |
Primary outcome
Maximum Plasma Concentration
Time frame: During the last dosing interval (hour 11-12 post-dose)
Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)
Average Concentration
Time frame: During the last dosing interval (hour 11-12 post-dose)
Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)
4 secondary outcomes
Time of Maximum Concentration
Time frame: During the last dosing interval (hour 11-12 post-dose)
Minimum Plasma Concentration
Time frame: During the last dosing interval (hour 11-12 post-dose)
Peak-Trough Fluctuation
Time frame: During the last dosing interval (hour 11-12 post-dose)
Nicotine Plasma Concentration
Time frame: One hour after start of treatment
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.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nicotine, Nicotine Lozenge and Nicotine gum in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
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 3 inclusion and 3 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 1 site in Sweden. 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?
Yes. Results are posted in the registry (first posted 19 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?
Maximum Plasma Concentration (time frame: During the last dosing interval (hour 11-12 post-dose)). The study lists 2 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.