A Study of the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of varenicline in Japanese smokers. Efficacy is evaluated by continuous quit rate and withdrawal symptoms of smokers. Safety is evaluated by adverse events, laboratory tests, and other safety tests.

Official Title
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A Multicenter, Open-Label Study Exploring the Efficacy and Safety of Varenicline in Japanese Smokers Motivated to Quit Smoking

Conditions
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Smoking

Intervention / Treatment
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* Drug: Varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese smokers motivated to quit smoking No period without smoking of more than 3 months Smoked an average of at least 10 cigarettes/day in the past year Exclusion Criteria: Subjects who have used nicotine replacement therapy within 1 month of the study screening visit Subjects intending to use nicotine replacement therapy or other smoking cessation treatments during the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5 mg BID<br> | Drug: Varenicline<br>* 0.5 mg BID for 7 weeks<br>* Other names: Chantix, Champix, CP-526,555;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carbon monoxide (CO)-confirmed 4-week continuous quit rate (4-week CQR) from Weeks 4 to 7. |  | Weeks 4-7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CO-confirmed 7-day Point Prevalence from Week 2 through Week 7. |  | Weeks 2-7 | 
| Continuous abstinence rate from target quit date (TQD) from Week 2 through Week 7. |  | Weeks 2-7 | 
| Average number of daily cigarettes smoked from Week 2 through Week 7. |  | Weeks 2-7 | 
| Assessment of withdrawal symptoms by Minnesota Nicotine Withdrawal Scales (MNWS) from Week 2 through Week 7. |  | Weeks 2-7 | 
| Assessment of satisfaction (desirable and aversive effects) obtained from smoking by Smoking Effects Inventory (SEI) (administered only to subjects who had smoked since the previous assessment) from Week 2 through Week 7. |  | Weeks 2-7 | 
| Assessment of tobacco craving by the Brief Questionnaire of Smoking Urges (QSU-Brief) from Week 2 through Week 7. |  | Weeks 2-7 | 
| Assessment of the effect of smoking cessation on subjects' quality of life by the Smoking Cessation Quality of Life (SCQoL) questionnaire from Week 2 through Week 7. |  | Weeks 2-7 | 
| Adverse events, laboratory test changes throughout the study. |  | Weeks 1-7 |