A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

Key facts

Study ID

NCT01244061

Run by

Pfizer

People needed

498

Starts

2010-12-01

Expected to finish

2012-11-01

Last updated by the study team

2014-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Smokers aged 18 years or above and wanting to stop smoking
• Smokers who have smoked an average of at least 10 cigarettes per day over the last 4 weeks
• Smokers who have tried before to stop smoking at least once with varenicline, and who took varenicline for at least 2 weeks
• The last attempt to stop smoking must be at least 3 months before entering the study

You may not qualify if…

• Individuals who have not tolerated varenicline well previously, or who have a current or prior medical or psychiatric history that would make entry into the trial inadvisable
• Individuals who have previously participated in clinical trials of varenicline
• Individuals who have been participating in another smoking cessation trial within the last 3 months, or other drug trial within the last 30 days

Where it is running

• Ronald Reagan University of California Los Angeles Medical Center — Los Angeles, California, United States
• University of California Los Angeles David Geffen School of Medicine — Los Angeles, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• The University of Maryland — College Park, Maryland, United States
• The Center for Pharmaceutical Research, PC — Kansas City, Missouri, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Clinical Research Associates, Inc. — Nashville, Tennessee, United States
• Australian Clinical Research Network — Maroubra, New South Wales, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• AusTrials Australia — Sherwood, Queensland, Australia
• Emeritus Research — Malvern, Victoria, Australia
• Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie — Edegem, Belgium
• Universitaire Ziekenhuizen Leuven/Pneumologie — Leuven, Belgium
• Centre Hospitalier Universitaire de Liege — Liège, Belgium
• Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire — Yvoir, Belgium
• Office of Dr. Ronald Collette — Burnaby, British Columbia, Canada
• White Hills Medical Clinic — St. John's, Newfoundland and Labrador, Canada
• Canadian Phase Onward Inc. — Toronto, Ontario, Canada
• Clinique des maladies Lipidiques de Quebec — Québec, Quebec, Canada
• Fakultni nemocnice Brno — Brno, Czechia
• Krajska nemocnice Liberec a.s., Plicni oddeleni — Liberec, Czechia
• Mestska nemocnice Ostrava, Plicni oddeleni — Ostrava, Czechia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• CHU de la Cavale Blanche — Brest, France

Full record on ClinicalTrials.gov

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