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

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: varenicline tartrate (CP-526, 555-18); Drug: Placebo

• Registration Number: NCT00594204
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Study Start: 2008-04
• Primary Completion: 2009-06
• Study Completion: 2009-08
• Results First Submitted: 2010-05-27
• Results First Submitted QC: 2010-05-27
• Status Verified: 2010-07
• Results First Posted: 2010-07-05
• Last Update Submitted: 2010-07-14
• Last Update Posted: 2010-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 593

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varenicline	varenicline tartrate (CP-526, 555-18)	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With 4-week Continuous Abstinence	Weeks 9 through 12	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Continuous Abstinence	Weeks 9 through 24	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
Number of Participants With Seven-day Point Prevalence of Abstinence	Week 12 and 24	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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇻🇪 Caracas, Venezuela