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

Phase 2

Withdrawn

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline Immediate Release 1 mg; Drug: Varenicline Controlled Release 2.4 mg; Drug: Placebo; Drug: Varenicline Controlled Release 1.2 mg; Drug: Varenicline Controlled Release 1.8 mg

• Registration Number: NCT00741884
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-22
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Study Start: 2010-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Varenicline Immediate Release 1 mg	-
Arm 3	Varenicline Controlled Release 2.4 mg	-
Arm 5	Placebo	-
Arm 1	Varenicline Controlled Release 1.2 mg	-
Arm 2	Varenicline Controlled Release 1.8 mg	-

Primary Outcome Measures

Name	Time	Method
Continuous abstinence from smoking for weeks 4-7, carbon monoxide confirmed	7 weeks

Secondary Outcome Measures

Name	Time	Method
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