An Alternative Dosing Schedule of Varenicline for Smoking Cessation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00835900
First received: February 3, 2009
Last updated: April 8, 2014
Last verified: April 2014

February 3, 2009
April 8, 2014
March 2009
June 2010   (final data collection date for primary outcome measure)
Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal. [ Time Frame: daily ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00835900 on ClinicalTrials.gov Archive Site
Rates of smoking cessation. [ Time Frame: 12 weeks after quit date. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Extended Varenicline for Smoking Cessation: A Pilot Study

The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: varenicline
    variable dosing schedule
    Other Name: Chantix
  • Drug: placebo
    placebo
  • Experimental: varenicline
    drug plus counseling.
    Intervention: Drug: varenicline
  • Active Comparator: placebo
    placebo plus counseling
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
July 2014
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • currently smoking at least 15 cigarettes daily
  • in good health
  • able to read and speak English fluently
  • have a home telephone and plan to reside in Western New York for 6 months
  • willing to make quit attempt
  • signed informed consent
  • who planned quit attempt.

Exclusion Criteria:

  • serious medical condition
  • depression or mental health condition requiring treatment in the past year
  • history of panic disorder, psychosis, bipolar disorder
  • alcohol or drug abuse in the past year
  • use of tobacco products other than cigarettes
  • current use of other cessation pharmacotherapies
  • pregnancy/planned pregnancy.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00835900
I 136208, Pfizer IIR-GA30523
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Pfizer
Principal Investigator: Martin C Mahoney, MD, PhD Roswell Park Cancer Institute
Roswell Park Cancer Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP