Tobacco DependenceNCT01368016
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
A study testing Nicotine in people with Tobacco Dependence, run by McNeil AB at 2 sites in Sweden.
Trial summary
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine. Read more about this study
- Who is it for?
- Ages 19 to 55 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
- 346 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2011to Jul 2011
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
- Body Mass Index (BMI) between 17.5 and 32.0 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.
Who cannot join
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product within one month preceding the first dose of study medication.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Clinical Pharmacology, McNeil AB
Lund, SE-222 20
Karolinska Trial Alliance (KTA), University Hospital Huddinge
Stockholm, SE-141 86
About this study
Official title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
Read the detailed description
This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.
The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.
Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.
- Conditions
- Tobacco Dependence
- Being tested
- Nicotine
- Keywords
- Smoking Cessation, Nicotine Pharmacodynamics
- 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
A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
NicotineDrug
Also called Nicorette® Freshfruit gum
A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits
| Study group | Role | What they receive |
|---|---|---|
| Experimental NRT | Experimental | A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits. Receives: Drug: Nicotine |
| Nicotine GUM | Active comparator | A single 4 mg dose of a marketed Nicotine Gum, 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.
Area Under the Curve (AUC): Urges to Smoke-vs-Time
Area under urges to smoke-vs.-time curve
Measured: During 5 hours post-dose
Secondary outcomes (1)
Amount of Nicotine Released
The amount of nicotine released 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 posted7 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2011
- Study completionJul 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 346 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
- NCT01368016
- Sponsor's protocol ID
- NICTDP2012
- Other IDs
- 2010-023268-42
- Status last verified
- Jul 2012
- First submitted
- 6 Jun 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
- Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01368016
- Acronym / sponsor ID
- NICTDP2012
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine Pharmacodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Jun 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.
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
Detailed description
This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.
The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.
Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental NRT | Experimental | Drug: NicotineA single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits. |
| Nicotine GUM | Active comparator | Drug: NicotineA single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
- Body Mass Index (BMI) between 17.5 and 32.0 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.
Key exclusion criteria (2 listed)
- Pregnancy, lactation or intended pregnancy.
- Treatment with an investigational product within one 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 marketedA single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits | Drug | Experimental NRT |
| NicotineAlso: Nicorette® Freshfruit gumA single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits | Drug | Nicotine GUM |
Primary outcome
Area Under the Curve (AUC): Urges to Smoke-vs-Time
Time frame: During 5 hours post-dose
Area under urges to smoke-vs.-time curve
1 secondary outcome
Amount of 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.
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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 study testing Nicotine in people with Tobacco Dependence, run by McNeil AB at 2 sites 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 4 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 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 2 sites 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?
Area Under the Curve (AUC): Urges to Smoke-vs-Time (time frame: During 5 hours post-dose). 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.