Tobacco DependencePhase 1NCT01321931
Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products
A Phase 1 study testing Nicotine in people with Tobacco Dependence, run by McNeil AB at 1 site in Sweden.
Trial summary
Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers. Read more about this study
- Who is it for?
- Ages 19 to 50 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Jun 2011
- Phase
- Phase 1
- 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 19 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
- BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
- 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.
- Willing and able to comply with all scheduled visits and study procedures
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.
- Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.
Read the detailed description
Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine
- 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.
NicotineDrug
Also called Not yet marketed
6 mg experimental Nicotine Replacement Therapy (NRT)
NicotineDrug
Also called Nicorette® Freshfruit Gum
4 mg marketed Nicotine Fruit Gum (NFG)
NicotineDrug
Also called NiQuitinTM Mint lozenge
4 mg marketed nicotine mint lozenge (NIQ)
| Study group | Role | What they receive |
|---|---|---|
| NRT 60 | Experimental | A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits Receives: Drug: Nicotine |
| NFG 60 | Active comparator | A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits Receives: Drug: Nicotine |
| NRT 90 | Experimental | A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits Receives: Drug: Nicotine |
| NFG 90 | Active comparator | A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits Receives: Drug: Nicotine |
| NIQ 60 | Active comparator | A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Average Concentration
Average Nicotine Plasma Concentration (Cav) within the last dosing interval
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Area Under the Curve
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Secondary outcomes (5)
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Measured: During 12 hours post-dose
Minimum Observed Concentration
Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Peak-Trough Fluctuation
Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Swing
Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin
Measured: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Nicotine Released
The amount of nicotine released from the product during product administration
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT01321931
- Sponsor's protocol ID
- NICTDP1081
- Other IDs
- 2010-023026-20
- Status last verified
- Jul 2012
- First submitted
- 22 Mar 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
- ClinicalTrials.gov ID
- NCT01321931
- Acronym / sponsor ID
- NICTDP1081
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Mar 2011 (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.
Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.
Detailed description
Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NRT 60 | Experimental | Drug: NicotineA 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits |
| NFG 60 | Active comparator | Drug: NicotineA 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits |
| NRT 90 | Experimental | Drug: NicotineA 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NFG 90 | Active comparator | Drug: NicotineA 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits |
| NIQ 60 | Active comparator | Drug: NicotineA 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
- BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
- 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.
- Willing and able to comply with all scheduled visits and study procedures
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.
- Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.
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 |
|---|---|---|
| NicotineAlso: Not yet marketed6 mg experimental Nicotine Replacement Therapy (NRT) | Drug | NRT 60, NRT 90 |
| NicotineAlso: Nicorette® Freshfruit Gum4 mg marketed Nicotine Fruit Gum (NFG) | Drug | NFG 60, NFG 90 |
| NicotineAlso: NiQuitinTM Mint lozenge4 mg marketed nicotine mint lozenge (NIQ) | Drug | NIQ 60 |
Primary outcome
Maximum Observed Plasma Concentration
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)
Average Concentration
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Average Nicotine Plasma Concentration (Cav) within the last dosing interval
Area Under the Curve
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)
5 secondary outcomes
Time of Maximum Concentration
Time frame: During 12 hours post-dose
Minimum Observed Concentration
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Peak-Trough Fluctuation
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Swing
Time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)
Nicotine Released
Time frame: 30 minutes
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 10 Jul 2012.
Related trials for Tobacco Dependence
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
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 Phase 1 study testing Nicotine 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 5 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 10 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Observed Plasma Concentration (time frame: within the last dosing interval (starting at 10.5-11 hours after first product administration)). 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 10 Jul 2012.