Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

NCT00594204 | Completed Phase 4 Results

• 1 other identifier: A3051080
• Study Type: interventional
• Target: 593
• Locations: 10 countries
• Sites: 40

Brief Summary

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 4-week Continuous Abstinence

  The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits

  Weeks 9 through 12

Secondary Outcomes (2)

• Number of Participants With Continuous Abstinence

  Weeks 9 through 24

• Number of Participants With Seven-day Point Prevalence of Abstinence

  Week 12 and 24

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Drug: varenicline tartrate (CP-526, 555-18)

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

varenicline tartrate (CP-526, 555-18) DRUG

1 mg twice a day for 12 weeks, starting with a 1-week titration period.

Also known as: Chantix, Champix

varenicline

Placebo DRUG

matching placebo 1 tablet twice a day for 12 weeks

placebo

Eligibility Criteria

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

You may qualify if:

• Current male or female cigarette smokers who are motivated to stop smoking.
• Smoked an average of 10 cigarettes per day during past year and the month prior to first visit.

You may not qualify if:

• Patients who have used a nicotine replacement product, bupropion, clonidine or notriptyline within the past 6 months.
• Patients currently with depression or diagnosed with depression in past 12 months.
• Past or present history of psychosis, panic disorder, or bipolar disorder.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (42)

Pfizer Investigational Site

Fortaleza, Ceará, 60864-190, Brazil

Location

Pfizer Investigational Site

Porto Alegre, Centro, RS, Brazil

Location

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Juiz de Fora, Minas Gerais, 36036-110, Brazil

Location

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Botucatu, São Paulo, 18618-000, Brazil

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São Paulo, São Paulo, 04012-909, Brazil

Location

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São Paulo, São Paulo, 04032-060, Brazil

Location

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São Paulo, São Paulo, 05019-010, Brazil

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Medellín, Antioquia, 0, Colombia

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Barranquilla, Atlántico, 0, Colombia

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San Pedro, Provincia de San José, Costa Rica

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Cairo, Egypt, Egypt

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Amman, Jordan, Jordan

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Beirut, Lebanon, Lebanon

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Beirut Lebanon, Lebanon, 00000, Lebanon

Location

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México, D.f., 14000, Mexico

Location

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Morelia, Michoacán, 58249, Mexico

Location

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Monterrey, Nuevo León, 64460, Mexico

Location

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Jeddah, 21499, Saudi Arabia

Location

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Riyadh, 11211, Saudi Arabia

Location

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Tygerberg, Cape Town, 7505, South Africa

Location

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Bloemfontein, Free State, 9300, South Africa

Location

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Benoni, Gauteng, 1501, South Africa

Location

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Midrand, Gauteng, 1685, South Africa

Location

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Pretoria, Gauteng, South Africa

Location

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Soweto, Johannesburg, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

Location

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Sydenham, Durban, KwaZulu-Natal, 4091, South Africa

Location

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Hillcrest, Pretoria, 0083, South Africa

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Pfizer Investigational Site

Cape Town, Western Cape, 7764, South Africa

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Paarl, Cape Town, Western Cape, 7647, South Africa

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Durban, 4091, South Africa

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Lyttelton, 0140, South Africa

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Dubai, United Arab Emirates, 0, United Arab Emirates

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Abu Dhabi, United Arab Emirates

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Al Ain City, 0, United Arab Emirates

Location

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Dubai, 0, United Arab Emirates

Location

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Jumeirah/Dubai, 0, United Arab Emirates

Location

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Ras Al Khaima, 0, United Arab Emirates

Location

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Caracas, Distrito Federal, 1011, Venezuela

Location

Pfizer Investigational Site

Barquisimeto, Lara, 3002, Venezuela

Location

Pfizer Investigational Site

Gran Caracas, Miranda, 1060, Venezuela

Location

Pfizer Investigational Site

Caracas, Venezuela

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

• Bolliger CT, Issa JS, Posadas-Valay R, Safwat T, Abreu P, Correia EA, Park PW, Chopra P. Effects of varenicline in adult smokers: a multinational, 24-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2011 Apr;33(4):465-77. doi: 10.1016/j.clinthera.2011.04.013.

  PMID: 21635992 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.govCallCenter@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: January 3, 2008
• First Posted: January 15, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 20, 2010
• Results First Posted: July 5, 2010

Record last verified: 2010-07

Locations

ZA (13); CO (1); EG (1); JO (1); BR (7); SA (2); AE (6); ME (3); LE (2); VE (4)