NCT00143325

Brief Summary

Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
730

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2005

Geographic Reach
5 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 4, 2007

Status Verified

June 1, 2007

First QC Date

August 31, 2005

Last Update Submit

June 1, 2007

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Secondary Outcomes (6)

  • Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52

  • 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52

  • 4-week Point Prevalence of abstinence at Week 52

  • Long-Term Quit Rate at Weeks 24 and 52

  • Minnesota Nicotine Withdrawal Scale

  • +1 more secondary outcomes

Interventions

varenicline (CP-526,555)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Palo Alto, California, United States

Location

Pfizer Investigational Site

Santa Ana, California, United States

Location

Pfizer Investigational Site

Farmington, Connecticut, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, United States

Location

Pfizer Investigational Site

Portland, Oregon, United States

Location

Pfizer Investigational Site

Brussels, Belgium

Location

Pfizer Investigational Site

Edegem, Belgium

Location

Pfizer Investigational Site

Ghent, Belgium

Location

Pfizer Investigational Site

Caen, France

Location

Pfizer Investigational Site

Clermont-Ferrand, France

Location

Pfizer Investigational Site

Limeil-Brévannes, France

Location

Pfizer Investigational Site

Metz, France

Location

Pfizer Investigational Site

Paris, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, France

Location

Pfizer Investigational Site

Amsterdam, Netherlands

Location

Pfizer Investigational Site

Enschede, Netherlands

Location

Pfizer Investigational Site

Maastricht, Netherlands

Location

Pfizer Investigational Site

Zutphen, Netherlands

Location

Pfizer Investigational Site

London, Surrey, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Pfizer Investigational Site

Nottingham, United Kingdom

Location

Related Publications (2)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

  • 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.

    PMID: 18263663DERIVED

Related Links

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2006

Last Updated

June 4, 2007

Record last verified: 2007-06

Locations

BE(3)GB(3)NL(4)FR(6)US(6)