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.

Conditions: For the treatment of tobacco dependence by relieving nicotine craving and withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit abruptly.
MedDRA version: 9.1Level: LLTClassification code 10008374Term: Cessation of smoking
MedDRA version: 9.1Level: LLTClassification code 10053325Term: Smoking cessation therapy
MedDRA version: 9.1Level: LLTClassification code 10059612Term: Tobacco withdrawal symptoms

Registration Number: EUCTR2008-006845-13-DE

Lead Sponsor: McNeil AB (Johnson & Johnson Consumer and Personal Products Worldwide, J&J CPPW)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 465

Inclusion Criteria

1. males and females 18 years or older,
2. daily cigarette smoker for the last three years or more,
3. CO level of at least 10 ppm after at least 15 smoke-free minutes,
4. motivated and willing to completely stop smoking from the day after the baseline visit and to stay smokefree,
5. willing to use NMS for at least 12 weeks,
6. female participants of child-bearing potential should have used a medically acceptable means of birth control for at least one month prior to the baseline visit and continue to use birth control during the study period and for one month after the last dose of study drug,
7. 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,
8. be willing and able to comply with all study procedures and attend the 11 scheduled visits for the 52 weeks duration of the study,
9. be willing and able to use an eDiary according to the provided instructions and willing to return the eDiary at the 12-week visit

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. current use of tobacco-containing products, other than cigarettes (e.g., snuff/snus, chewing tobacco, cigars, or pipe), or smoking of other substances,
2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence (e.g. acupuncture), during the previous 6 months,
3. unstable angina pectoris or myocardial infarction or stroke during the previous 3 months,
4. pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential),
5. suspected alcohol or drug abuse,
6. have a member of the same household who is also a subject in the current study,
7. participation in other clinical trials within the previous 3 months and during study participation,
8. an acute or chronic medical or psychiatric condition or previously diagnosed clinically important renal or hepatic disease, that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
9. subjects with presence of an oral lesion (suspected malignant lesion and/or erosive lesion), requiring further investigation such as biopsy.