Clinical trial NCT00691483: Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Official title: A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Keywords: smoking cessation
smoking treatment
patient self-selected quit date
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Men and women
* 18 to 75 yrs old
* Motivated to stop smoking
* Smoke at least 10 cigarettes/day

Exclusion Criteria:

* Active psychiatric disease
* Severe or unstable cardiovascular or pulmonary disease
* Current or recent treatment to stop smoking
* Previous use of varenicline

Primary outcomes:
measure: Percentage of Participants With 4-week Continuous Abstinence (CA)
timeFrame: Week 9 through Week 12
Secondary outcomes:
measure: Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24
timeFrame: Week 9 through Week 24
measure: Percentage of Participants With Long Term Quit Through Week 24
timeFrame: Week 9 through Week 24
measure: Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)
timeFrame: Week 12 and Week 24
measure: Percentage of Participants With 4-week Point Prevalence of Nonsmoking
timeFrame: Week 24
Other outcomes:
measure: Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12
timeFrame: Baseline through Week 5
Locations:
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bridgeville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Santo André
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Gwei Shan Township, Taoyuan County
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.
citation: Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.