Smoking cessation MedDRA version: 9.1 Level: LLT Classification code 10057852 Term: Nicotine dependence MedDRA version: 9.1 Level: LLT Classification code 10059612 Term: Tobacco withdrawal symptoms
Conditions
Sponsors
McNeil AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 stop smoking and to be willing to use NMS for the first 3 weeks, 5. female participants of child-bearing potential should have used a medically acceptable means of birth control (see section 7.4 in protocol) 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 medication, 6. 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, 7. be willing and able to comply with all study procedures and attend the two scheduled visits and accept a safety follow up telephone call with questions 30 days after the last study visit, and to use an eDiary according to instructions which will be returned at the 3-weeks 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
Exclusion criteria: 1. current use of tobacco-containing products, other than cigarette (e.g., snuff/snus, chewing tobacco, cigars, or pipe), 2. use of other NRT, bupropion, or varenicline, or undergoing any treatment for tobacco dependence during the previous 3 months, 3. unstable angina pectoris or myocardial infarction 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. participation in other clinical trials within the previous three months and during study participation, 7. a severe 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate and evaluate subjects’ NMS usage patterns during a three-week period when subjects are given either fixed or flexible directions for use for smoking cessation. Specifically, mean hourly and daily spray consumption as well as maximum usage during specified time intervals will be examined. This will be separately evaluated for subjects who do, and do not, meet the criteria for continuous abstinence, respectively.;Secondary Objective: For continuous abstainers: • to evaluate craving and withdrawal symptoms during three weeks of product use (daily ratings during the first two weeks and one rating on treatment day number 20), • to assess the level of nicotine substitution by measuring saliva cotinine levels at baseline visit and week 3, For all subjects: • to evaluate self-reported carbon monoxide (CO) -verified continuous abstinence at week 3, • to evaluate the product acceptability of NMS at week 3, and • to evaluate the safety and adverse event profile of NMS;Primary end point(s): • mean hourly and daily number of spray doses used during weeks 1, 2, and 3, as well as throughout the study, • maximum number of spray doses used during any - 30-minute time period; - 1-hour time period; - 24-hour time period; | — |
Countries
United Kingdom
Outcome results
None listed