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An Alternative Dosing Schedule of Varenicline for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00835900
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 3, 2009
First Posted Date  ICMJE February 4, 2009
Results First Submitted Date  ICMJE March 13, 2017
Results First Posted Date  ICMJE May 30, 2017
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Changes in smoking behavior, as well as smoking satisfaction, craving, and withdrawal. [ Time Frame: daily ]
Change History Complete list of historical versions of study NCT00835900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2009)
Rates of Smoking Cessation. [ Time Frame: 12 weeks after quit date. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Official Title  ICMJE Extended Varenicline for Smoking Cessation: A Pilot Study
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: varenicline
    variable dosing schedule
    Other Name: Chantix
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: varenicline
    drug plus counseling.
    Intervention: Drug: varenicline
  • Active Comparator: placebo
    placebo plus counseling
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00835900
Other Study ID Numbers  ICMJE I 136208
Pfizer IIR-GA30523
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roswell Park Cancer Institute
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Martin C Mahoney, MD, PhD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date April 2017

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