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

NCT01244061 | Completed Phase 4 Results DMC

• 1 other identifier: A3051139
• Study Type: interventional
• Target: 498
• Locations: 8 countries
• Sites: 37

Brief Summary

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).

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• CAR From Week 9 Through Week 52

  Week 9 through Week 52

• CAR From Week 9 Through Week 24

  Week 9 through Week 24

• 7-day Point Prevalence (PP) of Abstinence at Weeks 12, 24, and 52

  Weeks 12, 24 and 52

Study Arms (2)

Varenicline

EXPERIMENTAL

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline DRUG

Varenicline 1mg twice daily

Varenicline

Placebo DRUG

Matched placebo twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095-6984, United States

Location

University of California Los Angeles David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

The University of Maryland

College Park, Maryland, 20742, United States

Location

The Center for Pharmaceutical Research, PC

Kansas City, Missouri, 64114, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

AusTrials Australia

Sherwood, Queensland, 4075, Australia

Location

Emeritus Research

Malvern, Victoria, 3145, Australia

Location

Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie

Edegem, 2650, Belgium

Location

Universitaire Ziekenhuizen Leuven/Pneumologie

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire de Liege

Liège, 4000, Belgium

Location

Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire

Yvoir, 5530, Belgium

Location

Office of Dr. Ronald Collette

Burnaby, British Columbia, V5G 1T4, Canada

Location

White Hills Medical Clinic

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

Location

Clinique des maladies Lipidiques de Quebec

Québec, Quebec, G1V 4M6, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Krajska nemocnice Liberec a.s., Plicni oddeleni

Liberec, 460 01, Czechia

Location

Mestska nemocnice Ostrava, Plicni oddeleni

Ostrava, 728 80, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 120 00, Czechia

Location

CHU de la Cavale Blanche

Brest, 29609, France

Location

CHU Côte de Nacre, Unité de Coordination de Tabacologie

Caen, 14033, France

Location

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie

Göttingen, Germany, 37075, Germany

Location

Klinische Forschung Berlin

Berlin, 10787, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Ludwig Maximilians-Universitaet Muenchen

München, 80336, Germany

Location

FOCUS Clinical Drug Development GmbH

Neuss, 41460, Germany

Location

Synexus Thames Valley Clinical Research Centre

Reading, Berks, RG2 0TG, United Kingdom

Location

Synexus Lancashire Clinical Research Centre

Chorley, Lancashire, PR7 7NA, United Kingdom

Location

Synexus Scotland Clinical Research Centre

Glasgow, G20 0SP, United Kingdom

Location

Synexus, Merseyside Clinical Research Centre

Liverpool, L22 0LG, United Kingdom

Location

William Harvey Research Institute,

London, EC1M 6BQ, 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: 37142273 DERIVED

• 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.

  PMID: 24911368 DERIVED

Related Links

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

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

One SAE, exposure via semen, was not included under the Adverse Events since this event was considered to be experienced by a non-study participant, who was the study participant's partner. This event was coded as nonserious in the safety database.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 9, 2014
• Results First Posted: June 9, 2014

Record last verified: 2014-05

Locations

US (8); CZ (4); AU (4); CA (4); GB (5); BE (4); FR (3); DE (5)