Tobacco DependenceNCT01084603
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
A study testing Oral Nicotine, NiQuitinTM Nicotine Lozenge and Nicorette® 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 single-dose 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, NiQuitinTM Nicotine Lozenge and Nicorette® Nicotine Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Jun 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 15 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 months preceding the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-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 single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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, NiQuitinTM Nicotine Lozenge, Nicorette® 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 Experimental nicotine 1 mg
A new l mg oral nicotine product
NiQuitinTM Nicotine LozengeDrug
Also called NiQuitinTM lozenge
A marketed 4 mg Nicotine lozenge
Nicorette® Nicotine GumDrug
Also called Nicorette® gum
A marketed 4 mg Nicotine Gum
| Study group | Role | What they receive |
|---|---|---|
| Oral Nicotine 1 | Experimental | One oral administration of 1 mg nicotine Receives: Drug: Oral Nicotine |
| Oral Nicotine 2 | Experimental | Two oral administrations of 1 mg nicotine Receives: Drug: Oral Nicotine |
| Oral Nicotine 4 | Experimental | Four oral administrations of 1 mg nicotine Receives: Drug: Oral Nicotine |
| NiQuitinTM Nicotine Lozenge 4 mg | Active comparator | One 4 mg marketed nicotine lozenge Receives: Drug: NiQuitinTM Nicotine Lozenge |
| Nicorette® Gum 4 mg | Active comparator | One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes Receives: Drug: Nicorette® 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 12 hours after start of administration
Bioavailability
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).
Measured: 12 hours
Secondary outcomes (4)
Nicotine Plasma Concentration
Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
Measured: During 10 minutes after start of administration
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Measured: During 12 hours after start of administration
Terminal Elimination Rate Constant
The terminal nicotine elimination rate constant (Lamda z)
Measured: During 12 hours after start of administration
Released Nicotine
The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
Measured: After 30 minutes' chewing
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 startMar 2009
- Primary completionMay 2009
- Study completionJun 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
- 45 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
- NCT01084603
- Sponsor's protocol ID
- NICTDP1065/A6431116
- Other IDs
- 2008-006280-36, 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
- Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01084603
- Acronym / sponsor ID
- NICTDP1065/A6431116
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Mar 2010 (estimated)
- Results
- Posted 8 Jul 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 single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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 1 | Experimental | Drug: Oral NicotineOne oral administration of 1 mg nicotine |
| Oral Nicotine 2 | Experimental | Drug: Oral NicotineTwo oral administrations of 1 mg nicotine |
| Oral Nicotine 4 | Experimental | Drug: Oral NicotineFour oral administrations of 1 mg nicotine |
| NiQuitinTM Nicotine Lozenge 4 mg | Active comparator | Drug: NiQuitinTM Nicotine LozengeOne 4 mg marketed nicotine lozenge |
| Nicorette® Gum 4 mg | Active comparator | Drug: Nicorette® Nicotine GumOne marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes |
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 15 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 (2 listed)
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product or donation or loss of blood within 3 months preceding the first dose of study medication.
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: Experimental nicotine 1 mgA new l mg oral nicotine product | Drug | Oral Nicotine 1, Oral Nicotine 2, Oral Nicotine 4 |
| NiQuitinTM Nicotine LozengeAlso: NiQuitinTM lozengeA marketed 4 mg Nicotine lozenge | Drug | NiQuitinTM Nicotine Lozenge 4 mg |
| Nicorette® Nicotine GumAlso: Nicorette® gumA marketed 4 mg Nicotine Gum | Drug | Nicorette® Gum 4 mg |
Primary outcome
Maximum Plasma Concentration
Time frame: During 12 hours after start of administration
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)
Bioavailability
Time frame: 12 hours
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).
4 secondary outcomes
Nicotine Plasma Concentration
Time frame: During 10 minutes after start of administration
Time of Maximum Concentration
Time frame: During 12 hours after start of administration
Terminal Elimination Rate Constant
Time frame: During 12 hours after start of administration
Released Nicotine
Time frame: After 30 minutes' chewing
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, NiQuitinTM Nicotine Lozenge and Nicorette® 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 2 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 8 Jul 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 12 hours after start of administration). 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.