A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Pfizer498 enrolled

Overview

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

498

Conditions

Smoking Cessation

Interventions

VareniclineDRUG

Varenicline 1mg twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Smokers aged 18 years or above and wanting to stop smoking * Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks * Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks * The last attempt to stop smoking must be at least 3 months before entering the study Exclusion Criteria: * Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable * Individuals who have previously participated in clinical trials of varenicline * Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days

Locations (37)

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, United States

University of California Los Angeles David Geffen School of Medicine

Los Angeles, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States

The University of Maryland

College Park, Maryland, United States

Outcomes

Primary Outcomes

Continuous Abstinence Rate (CAR) From Week 9 Through Week 12

The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)\> 10ppm at any visits during this time frame.

Time frame: Week 9 through Week 12

Secondary Outcomes

CAR From Week 9 Through Week 52

The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO \>10 ppm at any of these visits during this time frame.

Time frame: Week 9 through Week 52

CAR From Week 9 Through Week 24

The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO \>10 ppm at any of these visits during this time frame.

Time frame: Week 9 through Week 24

7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52

The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was \>10 ppm at the time point being summarized. Participants were considered responders independently at each visit.

Time frame: Weeks 12, 24 and 52