Smoking CessationNCT00882375
Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy
A study testing Nicotine in people with Smoking Cessation, run by McNeil AB at 3 sites in 2 countries.
Trial summary
A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 479 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2009to Jun 2010
- 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 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
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
University of Heidelberg
Mannheim, 68159
University Hospital of Tuebingen
Tübingen, 72076
About this study
Official title: Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.
A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
Read the detailed description
Efficacy and safety study following use of a novel nicotine replacement therapy.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine, Placebo
- Keywords
- Smoking Cessation
- 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 NRT
Nicotine administered using novel NRT user instructions
PlaceboDrug
Placebo administered using novel NRT user instructions
| Study group | Role | What they receive |
|---|---|---|
| Nicotine | Experimental | Nicotine Receives: Drug: Nicotine |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Measured: at weeks 2, 6, 24 and 52
Secondary outcomes (5)
Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.
Measured: weeks 2, 4, 8, 12, 16, and 20
Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Measured: weeks 4, 6, 8, 12, 16, 20, 24, and 52
Ratings of craving/urge to smoke and withdrawal symptoms.
Measured: baseline to 24 weeks
Cotinine levels in saliva.
Measured: baseline, and weeks 2, 6, 12 and 24
Product acceptability
Measured: weeks 1, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 479 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
- NCT00882375
- Sponsor's protocol ID
- A6431111
- Other IDs
- 2008-006845-13, 2008
- Status last verified
- Jun 2012
- First submitted
- 15 Apr 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Roche F, Pepin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Levy P, Barthelemy JC; PROOF Study Group. At 68 years, unrecognised sleep apnoea is associated with elevated ambulatory blood pressure. Eur Respir J. 2012 Sep;40(3):649-56. doi: 10.1183/09031936.00162710. Epub 2012 Apr 20.
PubMed 22523363
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy. A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 52 Week Study in Smokers Motivated to Quit.
- ClinicalTrials.gov ID
- NCT00882375
- Acronym / sponsor ID
- A6431111
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Apr 2009 (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 a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.
Detailed description
Efficacy and safety study following use of a novel nicotine replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine | Experimental | Drug: NicotineNicotine |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
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 |
|---|---|---|
| NicotineAlso: NRTNicotine administered using novel NRT user instructions | Drug | Nicotine |
| PlaceboPlacebo administered using novel NRT user instructions | Drug | Placebo |
Primary outcome
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Time frame: at weeks 2, 6, 24 and 52
5 secondary outcomes
Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.
Time frame: weeks 2, 4, 8, 12, 16, and 20
Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
Time frame: weeks 4, 6, 8, 12, 16, 20, 24, and 52
Ratings of craving/urge to smoke and withdrawal symptoms.
Time frame: baseline to 24 weeks
Cotinine levels in saliva.
Time frame: baseline, and weeks 2, 6, 12 and 24
Product acceptability
Time frame: weeks 1, 6 and 12
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 2 Jul 2012.
- Derived from this study: PubMed 22523363Roche F, Pepin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Levy P, Barthelemy JC; PROOF Study Group. At 68 years, unrecognised sleep apnoea is associated with elevated ambulatory blood pressure. Eur Respir J. 2012 Sep;40(3):649-56. doi: 10.1183/09031936.00162710. Epub 2012 Apr 20.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine in people with Smoking Cessation, run by McNeil AB at 3 sites in 2 countries.
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 2 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 3 sites in Germany, Denmark. 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. Some participants in this study may receive a placebo. 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?
Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm. (time frame: at weeks 2, 6, 24 and 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00882375, which also lists 1 linked publication.
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 2 Jul 2012.