Tobacco DependenceNCT01228617
Single-dose Pharmacokinetics of Oral Nicotine Replacement Products
A study testing Nicotine and Nicotine Gum in people with Tobacco Dependence, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Sweden.
Trial summary
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum. 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?
- Nicotine and Nicotine Gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Oct 2007
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy smokers, smoking at least 10 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Trial Unit, Clinical Research and Trial Centre
Lund, SE-221 85
About this study
Official title: Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.
Read the detailed description
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine, 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.
NicotineDrug
Also called Not yet marketed
Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
Nicotine GumDrug
Also called Nicorette®
Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| A1 Short, no buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| A2 Short, low buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| A3 Short, high buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| B1 Long, no buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| B2 Long, low buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| B3 Long, high buffer | Experimental | Nicotine / not yet marketed Receives: Drug: Nicotine |
| R = Nicotine Gum | Active comparator | Nicorette® Gum Receives: Drug: Nicotine Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration
The maximum observed nicotine concentration in plasma (Cmax)
Measured: Baseline to 10 hours post-dose
Area under the Curve
The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
Measured: 10 hours post-dose
Secondary outcomes (3)
Time to Maximum Concentration
Time to Maximum Concentration (Tmax)
Measured: 10 hours post-dose
Residual Nicotine
The amount of residual nicotine in the product after being chewed.
Measured: 30 minutes
Dissolution Time
Actual time required for oral dissolution of new NRT products following product administration
Measured: 10 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startSep 2007
- Primary completionOct 2007
- Study completionOct 2007
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228617
- Sponsor's protocol ID
- A6431114-NICTDP1063
- Status last verified
- Oct 2011
- First submitted
- 25 Oct 2010
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Pharmacokinetics of Oral Nicotine Replacement Products - An Exploratory Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01228617
- Acronym / sponsor ID
- A6431114-NICTDP1063
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 26 Oct 2010 (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.
This is an explorative study comparing new prototypes of Nicotine Replacement Products with Nicorette® gum.
Detailed description
This study included 40 subjects who were randomly assigned to one of eight treatment sequences. In four of the sequences, the three prototypes with the shorter dissolution time and the reference were used; in the remaining four sequences, the three prototypes with the longer dissolution time and the reference were used. Hence, half of the subjects received the Short prototypes and half received the Long prototypes. Subjects in both treatment groups (short and long) attended four treatment visits, each of 11 hours' duration, and periods of at least 36 hours' duration between treatment visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A1 Short, no buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| A2 Short, low buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| A3 Short, high buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| B1 Long, no buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| B2 Long, low buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| B3 Long, high buffer | Experimental | Drug: NicotineNicotine / not yet marketed |
| R = Nicotine Gum | Active comparator | Drug: Nicotine GumNicorette® Gum |
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 10 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 month 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 |
|---|---|---|
| NicotineAlso: Not yet marketedFollowing a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day | Drug | A1 Short, no buffer, A2 Short, low buffer, A3 Short, high buffer, B1 Long, no buffer, B2 Long, low buffer, B3 Long, high buffer |
| Nicotine GumAlso: Nicorette®Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes. | Drug | R = Nicotine Gum |
Primary outcome
Maximum Concentration
Time frame: Baseline to 10 hours post-dose
The maximum observed nicotine concentration in plasma (Cmax)
Area under the Curve
Time frame: 10 hours post-dose
The area under the plasma concentration-vs.-time curve until the last measurable concentration (AUCt)and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)
3 secondary outcomes
Time to Maximum Concentration
Time frame: 10 hours post-dose
Residual Nicotine
Time frame: 30 minutes
Dissolution Time
Time frame: 10 hours post-dose
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 6 Oct 2011.
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 study testing Nicotine and Nicotine Gum in people with Tobacco Dependence, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 6 Oct 2011. 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?
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 Concentration (time frame: Baseline to 10 hours 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 6 Oct 2011.