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

Pfizer593 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

593

Conditions

Smoking Cessation

Interventions

varenicline tartrate (CP-526, 555-18)DRUG

1 mg twice a day for 12 weeks, starting with a 1-week titration period.

PlaceboDRUG

matching placebo 1 tablet twice a day for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (42)

Outcomes

Primary Outcomes

Number of Participants With 4-week Continuous Abstinence

The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits

Time frame: Weeks 9 through 12

Secondary Outcomes

Number of Participants With Continuous Abstinence

The number of participants who, at each contact from Week 9 through the given timepoint, reported no smoking and no use of other nicotine-containing products (Treatment Phase) or tobacco products (Nontreatment Phase) since the last study contact(on the Nicotine Use Inventory) and who did not have CO \> 10 ppm

Time frame: Weeks 9 through 24

Number of Participants With Seven-day Point Prevalence of Abstinence

Number of participants who, at the given visit or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and who did not have CO \>10 ppm on that day

Time frame: Week 12 and 24

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Fortaleza, Ceará, Brazil

Pfizer Investigational Site

Porto Alegre, Centro, Brazil

Pfizer Investigational Site

Juiz de Fora, Minas Gerais, Brazil

Pfizer Investigational Site

Botucatu, São Paulo, Brazil

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Pfizer Investigational Site

Medellín, Antioquia, Colombia

Pfizer Investigational Site

Barranquilla, Atlántico, Colombia

Pfizer Investigational Site

San Pedro, Provincia de San José, Costa Rica

...and 32 more locations