NCT00143286

Brief Summary

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Geographic Reach
7 countries

24 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

April 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
6 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
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 Weeks 13 -24.

Secondary Outcomes (5)

  • Continuous abstinence Weeks 13-52

  • Long term quit rate at Week 52

  • 7-day Point Prevalence of abstinence at Weeks 24, 52

  • 4-week Point Prevalence of abstinence at Week 52

  • Time to first cigarette post randomization

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 10 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 (24)

Pfizer Investigational Site

Santa Ana, California, United States

Location

Pfizer Investigational Site

West Palm Beach, Florida, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, United States

Location

Pfizer Investigational Site

Mogadore, Ohio, United States

Location

Pfizer Investigational Site

Dallas, Texas, United States

Location

Pfizer Investigational Site

Seattle, Washington, United States

Location

Pfizer Investigational Site

Calgary, Alberta, Canada

Location

Pfizer Investigational Site

Halifax, Nova Scotia, Canada

Location

Pfizer Investigational Site

Ottawa, Ontario, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, Canada

Location

Pfizer Investigational Site

Cornwall, Prince Edward Island, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, Canada

Location

Pfizer Investigational Site

Prague, Czechia

Location

Pfizer Investigational Site

Hellerup, Copenhagen, Denmark

Location

Pfizer Investigational Site

Aarhus C, Denmark

Location

Pfizer Investigational Site

Frederikssund, Denmark

Location

Pfizer Investigational Site

Bergen, Norway

Location

Pfizer Investigational Site

Hønefoss, Norway

Location

Pfizer Investigational Site

Oslo, Norway

Location

Pfizer Investigational Site

Gothenburg, Sweden

Location

Pfizer Investigational Site

Helsingborg, Sweden

Location

Pfizer Investigational Site

Stockholm, Sweden

Location

Pfizer Investigational Site

London, Surrey, United Kingdom

Location

Pfizer Investigational Site

London, United Kingdom

Location

Related Publications (3)

  • 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

  • Hajek P, Tonnesen P, Arteaga C, Russ C, Tonstad S. Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. Addiction. 2009 Sep;104(9):1597-602. doi: 10.1111/j.1360-0443.2009.02646.x.

    PMID: 19686530DERIVED

  • Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.

    PMID: 16820548DERIVED

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

April 1, 2003

Study Completion

March 1, 2005

Last Updated

June 4, 2007

Record last verified: 2007-06

Locations

DK(3)US(6)CZ(1)CA(6)NO(3)SE(3)GB(2)