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

A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

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).

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Varenicline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Maroubra, New South Wales, Australia, 2035
      • Australian Clinical Research Network
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
    • Sherwood, Queensland, Australia, 4075
      • AusTrials Australia
  • Victoria
    • Malvern, Victoria, Australia, 3145
      • Emeritus Research
• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven/Pneumologie
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege
  • Yvoir, Belgium, 5530
    • Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire
• Canada
  • Quebec, Canada, G1V 4M6
    • Clinique des maladies lipidiques de Quebec
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 1T4
      • Office of Dr. Ronald Collette
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • White Hills Medical Clinic
  • Ontario
    • Toronto, Ontario, Canada, M3H 5S4
      • Canadian Phase Onward Inc.
• Czech Republic
  • Brno, Czech Republic, 625 00
    • Fakultní nemocnice Brno
  • Liberec 1, Czech Republic, 460 01
    • Krajska nemocnice Liberec a.s., Plicni oddeleni
  • Ostrava 1, Czech Republic, 728 80
    • Mestska nemocnice Ostrava, Plicni oddeleni
  • Praha 2, Czech Republic, 120 00
    • Vseobecna fakultni nemocnice v Praze
• France
  • Brest, France, 29609
    • CHU de la Cavale Blanche
  • Caen, France, 14033
    • CHU Côte de Nacre, Unité de Coordination de Tabacologie
  • Montpellier Cedex 5, France, 34295
    • Hopital Arnaud de Villeneuve
• Germany
  • Berlin, Germany, 10787
    • Klinische Forschung Berlin
  • Goettingen, Germany, 37075
    • Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie
  • Hamburg, Germany, 20253
    • Klinische Forschung Hamburg GmbH
  • Muenchen, Germany, 80336
    • Ludwig Maximilians-Universitaet Muenchen
  • Neuss, Germany, 41460
    • FOCUS Clinical Drug Development GmbH
• United Kingdom
  • Glasgow, United Kingdom, G20 0SP
    • Synexus Scotland Clinical Research Centre
  • Liverpool, United Kingdom, L22 0LG
    • Synexus, Merseyside Clinical Research Centre
  • London, United Kingdom, EC1M 6BQ
    • William Harvey Research Institute,
  • Berks
    • Reading, Berks, United Kingdom, RG2 0TG
      • Synexus Thames Valley Clinical Research Centre
  • Lancashire
    • Chorley, Lancashire, United Kingdom, PR7 7NA
      • Synexus Lancashire Clinical Research Centre
• United States
  • California
    • Los Angeles, California, United States, 90095-6984
      • Ronald Reagan University of California Los Angeles Medical Center
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles David Geffen School of Medicine
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates, Inc.
  • Maryland
    • College Park, Maryland, United States, 20742
      • The University of Maryland
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • The Center for Pharmaceutical Research, PC
  • Oregon
    • Portland, Oregon, United States, 97239-3098
      • Oregon Health and Science University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched placebo twice daily
Experimental: Varenicline	Drug: Varenicline; Varenicline 1mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Abstinence Rate (CAR) From Week 9 Through Week 12	The percentage of participants who, from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO)> 10ppm at any visits during this time frame.	Week 9 through Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAR From Week 9 Through Week 52	The percentage of participants who, from Week 9 through Week 52, reported no smoking (Weeks 9 through 52) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 52), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.	Week 9 through Week 52
CAR From Week 9 Through Week 24	The percentage of participants who, from Week 9 through Week 24, reported no smoking (Weeks 9 through 24) and no use of other nicotine-containing products (Weeks 9 through 12), or no use of other tobacco products (Weeks 13 through 24), since the last study visit/last contact (on the Nicotine Use Inventory) and who did not have CO >10 ppm at any of these visits during this time frame.	Week 9 through Week 24
7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52	The secondary endpoint of 7-day point prevalence of smoking cessation was determined by evaluating a participant's cigarette smoking status, and other nicotine (and/or other tobacco) use, based on the "last 7 days" questions in the Nicotine Use Inventory. Additionally, a participant was not considered a responder if the expired CO was >10 ppm at the time point being summarized. Participants were considered responders independently at each visit.	Weeks 12, 24 and 52

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): June 9, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051139