Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

Pfizer

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: varenicline tartrate (CP-526, 555-18); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00594204

A3051080

Details and patient eligibility

About

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Enrollment: 593 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current male or female cigarette smokers who are motivated to stop smoking.
• Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

Exclusion criteria

• Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
• Patients currently with depression or diagnosed with depression in past 12 months.
• Past or present history of psychosis, panic disorder, or bipolar disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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593 participants in 2 patient groups, including a placebo group

varenicline

Active Comparator group

Treatment:

Drug: varenicline tartrate (CP-526, 555-18)

placebo

Placebo Comparator group

Treatment:

Drug: Placebo