Clinical trial NCT00882375: Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
timeFrame: at weeks 2, 6, 24 and 52
Secondary outcomes:
measure: Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.
timeFrame: weeks 2, 4, 8, 12, 16, and 20
measure: Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.
timeFrame: weeks 4, 6, 8, 12, 16, 20, 24, and 52
measure: Ratings of craving/urge to smoke and withdrawal symptoms.
timeFrame: baseline to 24 weeks
measure: Cotinine levels in saliva.
timeFrame: baseline, and weeks 2, 6, 12 and 24
measure: Product acceptability
timeFrame: weeks 1, 6 and 12
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
city: Mannheim
country: Germany
facility: University of Heidelberg
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
citation: 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.