A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLEDSTUDY EVALUATING THE EFFICACY OF VARENICLINE IN CESSATION OFORAL TOBACCO USE

• Conditions: Cessation of oral smokeless tobacco use in current non-smokers.; MedDRA version: 9.1Level: LLTClassification code 10053325Term: Smoking cessation therapy

• Registration Number: EUCTR2008-000546-31-SE
• Lead Sponsor: Pfizer Ltd, Ramsgate Road,Sandwich,Kent CT13 9NJ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified