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

Phase 4

Completed

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Varenicline	Varenicline	-

Primary Outcome Measures

Name	Time	Method
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12	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.

Secondary Outcome Measures

Name	Time	Method
CAR From Week 9 Through Week 52	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.
CAR From Week 9 Through Week 24	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.
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52	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.

Locations (37): Ronald Reagan University of California Los Angeles Medical Center
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Los Angeles, California, United States
University of California Los Angeles David Geffen School of Medicine
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Los Angeles, California, United States
Avail Clinical Research, LLC
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DeLand, Florida, United States
Central Kentucky Research Associates, Inc.
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Lexington, Kentucky, United States
The University of Maryland
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College Park, Maryland, United States
The Center for Pharmaceutical Research, PC
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Kansas City, Missouri, United States
Oregon Health and Science University
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Portland, Oregon, United States
Clinical Research Associates, Inc.
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Nashville, Tennessee, United States
Australian Clinical Research Network
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Maroubra, New South Wales, Australia
Royal Brisbane and Women's Hospital
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Herston, Queensland, Australia
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Ronald Reagan University of California Los Angeles Medical Center
🇺🇸Los Angeles, California, United States