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

Study Overview
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Brief Summary
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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.

Official Title
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A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: varenicline tartrate (CP-526, 555-18)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: varenicline<br> | Drug: varenicline tartrate (CP-526, 555-18)<br>* 1 mg twice a day for 12 weeks, starting with a 1-week titration period.<br>* Other names: Chantix, Champix;|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* matching placebo 1 tablet twice a day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Weeks 9 through 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Week 12 and 24 |