Clinical trial NCT00594204: Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With 4-week Continuous Abstinence
timeFrame: Weeks 9 through 12
Secondary outcomes:
measure: Number of Participants With Continuous Abstinence
timeFrame: Weeks 9 through 24
measure: Number of Participants With Seven-day Point Prevalence of Abstinence
timeFrame: Week 12 and 24
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: Centro
city: Fortaleza
country: Brazil
facility: Pfizer Investigational Site
state: CE
city: Juiz de Fora
country: Brazil
facility: Pfizer Investigational Site
state: MG
city: Botucatu
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: San Pedro de Montes de Oca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
city: Cairo
country: Egypt
facility: Pfizer Investigational Site
city: Amman
country: Jordan
facility: Pfizer Investigational Site
city: Beirut Lebanon
country: Lebanon
facility: Pfizer Investigational Site
city: Beirut
country: Lebanon
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Jeddah
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Pfizer Investigational Site
city: Tygerberg
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Benoni
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Midrand
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Tshwane
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
state: Johannesburg
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu-Natal
city: Sydenham, Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwazulu-natal
city: Hillcrest
country: South Africa
facility: Pfizer Investigational Site
state: Pretoria
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Paarl, Cape Town
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Durban
country: South Africa
facility: Pfizer Investigational Site
city: Lyttelton
country: South Africa
facility: Pfizer Investigational Site
city: Abu Dhabi
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Al Ain
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Jumeirah/Dubai
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Ras Al Khaima
country: United Arab Emirates
facility: Pfizer Investigational Site
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Distrito Capital
city: Barquisimeto
country: Venezuela
facility: Pfizer Investigational Site
state: Lara
city: Gran Caracas
country: Venezuela
facility: Pfizer Investigational Site
state: Miranda
city: Caracas
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.