Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

NCT00691483 | Completed Phase 4 Results DMC

• 1 other identifier: A3051095
• Study Type: interventional
• Target: 659
• Locations: 14 countries
• Sites: 33

Brief Summary

The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.

Conditions

Smoking Cessation

Keywords

smoking cessation; smoking treatment; patient self-selected quit date

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 4-week Continuous Abstinence (CA)

  The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \>10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO \>10 ppm.

  Week 9 through Week 12

Secondary Outcomes (4)

• Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24

  Week 9 through Week 24

• Percentage of Participants With Long Term Quit Through Week 24

  Week 9 through Week 24

• Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)

  Week 12 and Week 24

• Percentage of Participants With 4-week Point Prevalence of Nonsmoking

  Week 24

Other Outcomes (1)

• Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12

  Baseline through Week 5

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

varenicline

EXPERIMENTAL

Drug: varenicline

Interventions

placebo DRUG

placebo tablet taken orally twice daily for 12 weeks

placebo

varenicline DRUG

varenicline tablets, 1 mg taken orally twice daily for 12 weeks

Also known as: Chantix, Champix

varenicline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• to 75 yrs old
• Motivated to stop smoking
• Smoke at least 10 cigarettes/day

You may not qualify if:

• Active psychiatric disease
• Severe or unstable cardiovascular or pulmonary disease
• Current or recent treatment to stop smoking
• Previous use of varenicline

Sponsors & Collaborators

• Pfizer: lead

Study Sites (33)

Pfizer Investigational Site

Litchfield Park, Arizona, 85340, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Santa Ana, California, 92705, United States

Location

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Milford, Massachusetts, 01757, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68116-2004, United States

Location

Pfizer Investigational Site

Endwell, New York, 13760, United States

Location

Pfizer Investigational Site

Bridgeville, Pennsylvania, 15017, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19146, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

Pfizer Investigational Site

Buenos Aires, C1405BCH, Argentina

Location

Pfizer Investigational Site

Santo André, São Paulo, 09060-650, Brazil

Location

Pfizer Investigational Site

Calgary, Alberta, T1Y 6J4, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 4M6, Canada

Location

Pfizer Investigational Site

Shenyang, Liaoning, 110016, China

Location

Pfizer Investigational Site

Beijing, 100020, China

Location

Pfizer Investigational Site

Guangzhou, 510120, China

Location

Pfizer Investigational Site

Brno, 656 91, Czechia

Location

Pfizer Investigational Site

Prague, 120 00, Czechia

Location

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Berlin, 10787, Germany

Location

Pfizer Investigational Site

Göttingen, 37075, Germany

Location

Pfizer Investigational Site

Budapest, 1525, Hungary

Location

Pfizer Investigational Site

Debrecen, 4012, Hungary

Location

Pfizer Investigational Site

Pisa, 56124, Italy

Location

Pfizer Investigational Site

Monterrey, Nuevo León, 64460, Mexico

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Gwei Shan Township, Taoyuan County, 333, Taiwan

Location

Pfizer Investigational Site

Kaohsiung City, 813, Taiwan

Location

Pfizer Investigational Site

London, SW18 4DD, 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: 37142273 DERIVED

• Hughes JR, Russ C, Messig MA. Association of deferring a quit attempt with smoking cessation success: a secondary analysis. J Subst Abuse Treat. 2014 Feb;46(2):264-7. doi: 10.1016/j.jsat.2013.08.015. Epub 2013 Sep 24.

  PMID: 24074849 DERIVED

• Rennard S, Hughes J, Cinciripini PM, Kralikova E, Raupach T, Arteaga C, St Aubin LB, Russ C; Flexible Quit Date Study Group. A randomized placebo-controlled trial of varenicline for smoking cessation allowing flexible quit dates. Nicotine Tob Res. 2012 Mar;14(3):343-50. doi: 10.1093/ntr/ntr220. Epub 2011 Nov 11.

  PMID: 22080588 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

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 20, 2015
• Results First Posted: September 30, 2010

Record last verified: 2015-10

Locations

US (12); HU (2); BR (1); CA (2); CN (3); CZ (2); DE (2); TW (2); GB (1); FR (1); AR (1); IT (1); ME (1); KR (2)