Smoking Cessation Clinical Trial
Official title:
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)
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.
Status | Completed |
Enrollment | 593 |
Est. completion date | August 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Pfizer Investigational Site | Botucatu | SP |
Brazil | Pfizer Investigational Site | Fortaleza | CE |
Brazil | Pfizer Investigational Site | Juiz de Fora | MG |
Brazil | Pfizer Investigational Site | Porto Alegre | Centro |
Brazil | Pfizer Investigational Site | Sao Paulo | SP |
Brazil | Pfizer Investigational Site | Sao Paulo | SP |
Brazil | Pfizer Investigational Site | Sao Paulo | SP |
Colombia | Pfizer Investigational Site | Barranquilla | Atlantico |
Colombia | Pfizer Investigational Site | Medellin | Antioquia |
Costa Rica | Pfizer Investigational Site | San Pedro de Montes de Oca | San Jose |
Egypt | Pfizer Investigational Site | Cairo | |
Jordan | Pfizer Investigational Site | Amman | |
Lebanon | Pfizer Investigational Site | Beirut | |
Lebanon | Pfizer Investigational Site | Beirut Lebanon | |
Mexico | Pfizer Investigational Site | Mexico | D.f. |
Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
Mexico | Pfizer Investigational Site | Morelia | Michoacan |
Saudi Arabia | Pfizer Investigational Site | Jeddah | |
Saudi Arabia | Pfizer Investigational Site | Riyadh | |
South Africa | Pfizer Investigational Site | Benoni | Gauteng |
South Africa | Pfizer Investigational Site | Bloemfontein | Free State |
South Africa | Pfizer Investigational Site | Cape Town | Western Cape |
South Africa | Pfizer Investigational Site | Durban | Kwazulu-Natal |
South Africa | Pfizer Investigational Site | Durban | |
South Africa | Pfizer Investigational Site | Hillcrest | Pretoria |
South Africa | Pfizer Investigational Site | Lyttelton | |
South Africa | Pfizer Investigational Site | Midrand | Gauteng |
South Africa | Pfizer Investigational Site | Paarl, Cape Town | Western Cape |
South Africa | Pfizer Investigational Site | Soweto | Johannesburg |
South Africa | Pfizer Investigational Site | Sydenham, Durban | Kwazulu-natal |
South Africa | Pfizer Investigational Site | Tshwane | Gauteng |
South Africa | Pfizer Investigational Site | Tygerberg | Cape Town |
United Arab Emirates | Pfizer Investigational Site | Abu Dhabi | |
United Arab Emirates | Pfizer Investigational Site | Al Ain | |
United Arab Emirates | Pfizer Investigational Site | Dubai | |
United Arab Emirates | Pfizer Investigational Site | Jumeirah/Dubai | |
United Arab Emirates | Pfizer Investigational Site | Ras Al Khaima | |
Venezuela | Pfizer Investigational Site | Barquisimeto | Lara |
Venezuela | Pfizer Investigational Site | Caracas | |
Venezuela | Pfizer Investigational Site | Caracas | Distrito Capital |
Venezuela | Pfizer Investigational Site | Gran Caracas | Miranda |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Brazil, Colombia, Costa Rica, Egypt, Jordan, Lebanon, Mexico, Saudi Arabia, South Africa, United Arab Emirates, Venezuela,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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