This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

An Alternative Dosing Schedule of Varenicline for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00835900
First received: February 3, 2009
Last updated: April 24, 2017
Last verified: April 2017
February 3, 2009
April 24, 2017
March 2009
July 2010   (Final data collection date for primary outcome measure)
Change in Smoking Behavior [ Time Frame: Change in cigarettes per day from Week 2 to Week 5 ]
Change in cigarettes per day from Week 2 to Week 5
Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal. [ Time Frame: daily ]
Complete list of historical versions of study NCT00835900 on ClinicalTrials.gov Archive Site
Rates of Smoking Cessation. [ Time Frame: 12 weeks after quit date. ]
To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers.
Rates of Smoking Cessation. [ Time Frame: 12 weeks after quit date. ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
 
Completed
60
July 2015
July 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00835900
I 136208
Pfizer IIR-GA30523
Yes
Not Provided
Not Provided
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 2017

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