A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult smokers.

Official Title
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A Phase 2, Seven Week, Double-Blind, Placebo Controlled, Randomized, Parallel Group Study To Evaluate The Safety And Efficacy Of Three Doses Of A Controlled Release Formulation Of Varenicline For Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Varenicline Controlled Release 1.2 mg
* Drug: Varenicline Controlled Release 1.8 mg
* Drug: Varenicline Controlled Release 2.4 mg
* Drug: Varenicline Immediate Release 1 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female cigarette smokers between the ages of 18 and 75 years, inclusive, who are motivated to stop smoking. Females of non-childbearing potential (surgically sterilized or at least 2 years postmenopausal) who are not nursing may be included. Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Subjects with clinically significant cardiovascular disease in the past 6 months. Subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior or subjects considered to have serious suicidal ideation or suicidal behavior within the past 12 months. Subjects having active suicidal ideation or behavior identified at Screen or Baseline. Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, anxiety disorder, hostility or aggression disorder, perceptual/thinking disturbances, psychosis, or bipolar disorder.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Varenicline Controlled Release 1.2 mg<br>* Varenicline CR tablet 1.2 mg BID for 7 weeks<br>|
| Experimental: Arm 2<br> | Drug: Varenicline Controlled Release 1.8 mg<br>* Varenicline CR tablet 1.8 mg BID for 7 weeks<br>|
| Experimental: Arm 3<br> | Drug: Varenicline Controlled Release 2.4 mg<br>* Varenicline CR tablet 2.4 mg BID for 7 weeks<br>|
| Active Comparator: Arm 4<br> | Drug: Varenicline Immediate Release 1 mg<br>* Varenicline IR tablet 1 mg BID for 7 weeks<br>|
| Placebo Comparator: Arm 5<br> | Drug: Placebo<br>* Placebo BID for 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7- day point prevalence of non-smoking at week 7 |  | 7 days | 
| Scores on the Minnesota Nicotine Withdrawal Scale subscales |  | 7 weeks | 
| Scores on the Modified Cigarette Evaluation Questionaire subscales |  | 7 weeks | 
| PK analysis |  | 7 weeks | 
| Safety Assessments: adverse events, C-SSRs, vital signs, body weight |  | 7 weeks |