Smoking CessationPhase 2NCT01075659
Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
A Phase 2 study testing Nicotine in people with Smoking Cessation, run by McNeil AB at 1 site 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
- Smoking Cessation
- What is being tested?
- Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2010to May 2010
- Phase
- Phase 2
- 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 smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up.
- 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.
- Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
- Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
- Prior regular use of any of the investigational products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge: 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 compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine
- Keywords
- Smoking Cessation, VAS, Urges to smoke
- Medical subject headings
- 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
Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
NicotineDrug
Also called NiQuitin™ lozenge 2 mg
Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
NicotineDrug
Also called NiQuitinTM lozenge 4 mg
Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| LHN1548 | Experimental | Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. Receives: Drug: Nicotine |
| 2019706 | Active comparator | Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. Receives: Drug: Nicotine |
| 2020005 | Active comparator | Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period. Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
Measured: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
Secondary outcomes (4)
Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)
Measured: from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score
Measured: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke
Measured: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments
Measured: At the end of three separate visits, at least 36 hours apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT01075659
- Sponsor's protocol ID
- NICTDP2011
- Status last verified
- Jul 2012
- First submitted
- 24 Feb 2010
- 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 NiQuitin™ Lozenge: A Study in Healthy Smokers
- ClinicalTrials.gov ID
- NCT01075659
- Acronym / sponsor ID
- NICTDP2011
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, VAS, Urges to smoke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 25 Feb 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.
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 compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LHN1548 | Experimental | Drug: NicotineTwo single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
| 2019706 | Active comparator | Drug: NicotineTwo single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
| 2020005 | Active comparator | Drug: NicotineTwo single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period. |
Who may qualify
- Ages
- 19 to 55 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 smoking within 30 minutes of waking up.
- 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 (4 listed)
- Pregnancy, lactation or intended pregnancy.
- Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
- Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
- Prior regular use of any of the investigational products.
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 marketedTwo single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period | Drug | LHN1548 |
| NicotineAlso: NiQuitin™ lozenge 2 mgTwo single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period. | Drug | 2019706 |
| NicotineAlso: NiQuitinTM lozenge 4 mgTwo single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period. | Drug | 2020005 |
Primary outcome
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
Time frame: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
4 secondary outcomes
Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)
Time frame: from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score
Time frame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke
Time frame: from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Study treatment acceptability, evaluated using pair-wise treatment comparisons of ordered categorical-scale assessments
Time frame: At the end of three separate visits, at least 36 hours apart
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine in people with Smoking Cessation, 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min) (time frame: from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively). 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.