Smoking CessationPhase 2NCT00764439
Pilot Study of a New Nicotine Replacement Therapy
A Phase 2 study testing Nicotine replacement therapy in people with Smoking Cessation, run by McNeil AB at 2 sites in United Kingdom.
Trial summary
Pilot study of a new nicotine replacement therapy for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine replacement therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2008to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older male and female cigarette smokers motivated and willing to stop smoking
- female participants of child-bearing potential should use a medically acceptable means of birth control
- evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate
Who cannot join
- unstable angina pectoris or myocardial infarction during the previous 3 months
- pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential)
- participation in other clinical trials within the previous three months and during study participation
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Primary Care and General Practice, University of Birmingham
Birmingham, B15 2TT
Tobacco Dependence Research Centre at Barts and The London Queen Mary's School of Medicine and Dentistry
London, E1 2AD
About this study
Official title: Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit
Pilot study of a new nicotine replacement therapy for smoking cessation.
Read the detailed description
This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine replacement therapy
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine replacement therapyDrug
Also called NRT
Nicotine replacement therapy with Standard NRT user direction
Nicotine replacement therapyDrug
Also called NRT
Nicotine replacement therapy with a Novel NRT user direction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard NRT user direction Receives: Drug: Nicotine replacement therapy |
| 2 | Experimental | Novel NRT user direction Receives: Drug: Nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean hourly and daily number of doses used
Measured: throughout study
Secondary outcomes (6)
Mean number of NRT use occasions per day
Measured: Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms
Measured: Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
Measured: Day 1-21
Cotinine levels
Measured: At baseline and week 3
Product acceptability
Measured: At week 3 visit
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.
Measured: throughout duration of the study (+ 30 days for spontaneous SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, Global Medical Affairs & Clinical Research, McNeil AB, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764439
- Sponsor's protocol ID
- NICTDP2010
- Other IDs
- 2008-002498-11, 2008
- Status last verified
- Jul 2012
- First submitted
- 1 Oct 2008
- 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
- Pilot Study on Usage Patterns of a Novel Nicotine Replacement Therapy - A Multi-Center, Open, 3-Week Randomized Low Intervention Study of Two Different Directions for Use in Smokers Motivated to Quit
- ClinicalTrials.gov ID
- NCT00764439
- Acronym / sponsor ID
- NICTDP2010
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 2 Oct 2008 (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.
Pilot study of a new nicotine replacement therapy for smoking cessation.
Detailed description
This will be a pilot study of a new nicotine replacement therapy with two different directions for use in smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Nicotine replacement therapyStandard NRT user direction |
| 2 | Experimental | Drug: Nicotine replacement therapyNovel NRT user direction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older male and female cigarette smokers motivated and willing to stop smoking
- female participants of child-bearing potential should use a medically acceptable means of birth control
- evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate
Key exclusion criteria (3 listed)
- unstable angina pectoris or myocardial infarction during the previous 3 months
- pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential)
- participation in other clinical trials within the previous three months and during study participation
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 |
|---|---|---|
| Nicotine replacement therapyAlso: NRTNicotine replacement therapy with Standard NRT user direction | Drug | 1 |
| Nicotine replacement therapyAlso: NRTNicotine replacement therapy with a Novel NRT user direction | Drug | 2 |
Primary outcome
Mean hourly and daily number of doses used
Time frame: throughout study
6 secondary outcomes
Mean number of NRT use occasions per day
Time frame: Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms
Time frame: Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
Time frame: Day 1-21
Cotinine levels
Time frame: At baseline and week 3
Product acceptability
Time frame: At week 3 visit
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events and Serious Adverse Events , their frequency, severity, seriousness, and relationship to the investigational product.
Time frame: throughout duration of the study (+ 30 days for spontaneous SAEs)
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
Global Medical Affairs & Clinical Research, McNeil AB, Sweden
2 sites 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 replacement therapy in people with Smoking Cessation, run by McNeil AB at 2 sites in United Kingdom.
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 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 2 sites in United Kingdom. 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?
Mean hourly and daily number of doses used (time frame: throughout study). 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.