Clinical trial NCT00143325: An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
Official title: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 730
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: Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Subjects must have smoked an average of at least 15 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.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular disease in the past 6 months.

Primary outcomes:
measure: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Secondary outcomes:
measure: Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
measure: 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
measure: 4-week Point Prevalence of abstinence at Week 52
measure: Long-Term Quit Rate at Weeks 24 and 52
measure: Minnesota Nicotine Withdrawal Scale
measure: Smoking Effects Inventory
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Ana
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Caen
country: France
facility: Pfizer Investigational Site
city: Clermont-Ferrand
country: France
facility: Pfizer Investigational Site
city: Limeil Brevannes
country: France
facility: Pfizer Investigational Site
city: Limeil-Brevannes
country: France
facility: Pfizer Investigational Site
city: Metz CEDEX 01
country: France
facility: Pfizer Investigational Site
city: Metz Cedex 1
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre les Nancy
country: France
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Enschede
country: Netherlands
facility: Pfizer Investigational Site
city: Maastricht
country: Netherlands
facility: Pfizer Investigational Site
city: Zutphen
country: Netherlands
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.