Clinical Trials Logo
  1. Home
  2. Smoking Cessation
  3. NCT00143364
  4. Details
NCT00143364 Clinical Trial

A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00143364
Other study ID # A3051036
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated June 1, 2007
Start date June 2003
Est. completion date March 2005

Study information
Verified date June 2007
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.

Recruitment information / eligibility
Status Completed
Enrollment 1005
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

- Subjects who have used bupropion (Zyban or Wellbutrin) previously.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• varenicline (CP-526,555)

Locations
Country Name City State
United States Pfizer Investigational Site Albert Lea Minnesota
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Portland Maine
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
Secondary Continuous abstinence Weeks 9-52
Secondary Long-term Quit Rate Week 52
Secondary Continuous abstinence Weeks 9 -24
Secondary 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
Secondary 4-week Point Prevalence Abstinence at Week 52
Secondary Minnesota Nicotine Withdrawal Scale
Secondary Brief Questionnaire of Smoking Urges
Secondary Smoking Effects Inventory
Secondary Change from baseline in bodyweight
See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT04617444 - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function N/A
Completed NCT02796391 - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes Phase 2
Completed NCT03397511 - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City N/A
Not yet recruiting NCT05188287 - A Culturally Tailored Smartphone Application for African American Smokers N/A
Recruiting NCT05264428 - The Effect of Honey on Lessening the Withdrawal Symptoms N/A
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Completed NCT03187730 - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants Phase 4
Completed NCT03474783 - To Explore the Factors Affecting the Effectiveness of Smoking Cessation N/A
Completed NCT04635358 - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center N/A
Terminated NCT03670264 - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation N/A
Not yet recruiting NCT06307496 - VIDeOS for Smoking Cessation N/A
Completed NCT02905656 - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02997657 - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial N/A
Completed NCT02239770 - Pharmacokinetics of Nicotine Film in Smokers N/A
Completed NCT02562521 - A Smoking Cessation Intervention for Yale Dining Employees Phase 4
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A

External Links