Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

Pfizer

Status and phase: Completed; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: placebo; Drug: varenicline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691483

A3051095

Details and patient eligibility

About

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Enrollment: 659 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women
• 18 to 75 yrs old
• Motivated to stop smoking
• Smoke at least 10 cigarettes/day

Exclusion criteria

• Active psychiatric disease
• Severe or unstable cardiovascular or pulmonary disease
• Current or recent treatment to stop smoking
• Previous use of varenicline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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659 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

varenicline

Experimental group

Treatment:

Drug: varenicline