Cessation of oral smokeless tobacco use in current non-smokers. MedDRA version: 9.1 Level: LLT Classification code 10053325 Term: Smoking cessation therapy
Conditions
Interventions
Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Film-coated tablet
CAS Number: 249296-44-4
Current Sponsor code: Varenicline Tartrate
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Have evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of and has understood all pertinent aspects of the study. 2. Male or female daily smokeless tobacco users aged 18 years and older, who are motivated to stop use of all tobacco products. 3. Subjects must be daily users of nicotine containing smokeless tobacco and using smokeless tobacco on at least 8 occasions per day averaged over a week. 4. Have used smokeless tobacco for at least 1 year prior to screening with no period of abstinence >3 months in the past year. 5. If female, be not of childbearing potential (ie, surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner) for a least one month prior to the screening visit, and for the duration of the study period. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 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: Subjects with any of the following will not be included in the study: 1. Subjects using nicotine containing products (including smoking tobacco) other than smokeless tobacco for 3 months prior to screening. 2. Subjects with exhaled Carbon Monoxide (CO) =10 ppm at baseline. 3. Subjects who have used varenicline, bupropion, or NRT within 3 months of screening. 4. Subjects currently or within the past 12 months requiring treatment for depression or have a current or prior history of panic disorder, psychosis, bipolar disorder or any other serious mental illness. 5. Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months. 6. Subjects receiving concomitant treatment with another investigational drug within 30 days of the study baseline visit or with plans to take another investigational drug within 30 days of study completion (after Week 26 visit). 7. Subjects with an uncontrolled, unstable clinically significant medical condition (eg, renal, hepatic, endocrine, respiratory, cardiovascular, haematologic, immunologic, cerebrovascular disease, diabetic or have malignancy), which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations. 8. The contraindication of varenicline is hypersensitivity to the active substance or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of varenicline to placebo for cessation of use of smokeless tobacco assessed using the 4 week Continuous Quit Rate (CQR) at the end of treatment.;Secondary Objective: To compare varenicline with placebo for the Continuous Abstinence (CA) of smokeless tobacco from Weeks 9 through to 26. • Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of treatment (Week 12). • Compare varenicline with placebo for the 7 day Point Prevalence (PP) of abstinence at the end of study (Week 26). • Compare varenicline with placebo for the long term quit rate (LTQR) of smokeless tobacco from Weeks 9 through to 26. • To assess the safety and tolerability of varenicline with placebo, for 12 weeks of treatment in users of smokeless tobacco.;Primary end point(s): The 4-week Continuous Quit Rate (CQR) from smokeless tobacco use assessed for the 4 weeks prior to the end of treatment (Week 9 through to 12). This will be assessed using the nicotine use inventory (NUI) and confirmed by salivary cotinine at the weekly visits from Week 9 through to 12. | — |
Countries
Sweden
Outcome results
None listed