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Smoking Cessation Treatment for Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00931021
Recruitment Status : Terminated
First Posted : July 2, 2009
Last Update Posted : July 15, 2013
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE July 2, 2009
Last Update Posted Date July 15, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch. [ Time Frame: Eight weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00931021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
  • To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer. [ Time Frame: Eight weeks ]
  • To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. [ Time Frame: Eight weeks ]
  • To examine the effect of varenicline and nicotine patch on alcohol consumption. [ Time Frame: Eight weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation Treatment for Head and Neck Cancer Patients
Official Title  ICMJE Smoking Cessation Treatment for Head and Neck Cancer Patients
Brief Summary This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Varenicline (Chantix)
    2 mg
    Other Name: Chanitx
  • Drug: Nicotine Patch
    21 mg
Study Arms  ICMJE
  • Active Comparator: Varenicline (Chantix)
    Intervention: Drug: Varenicline (Chantix)
  • Active Comparator: Nicotine Patch
    Intervention: Drug: Nicotine Patch
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 Terminated
Actual Enrollment  ICMJE
 (submitted: July 12, 2013)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2009)
30
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 or older
  • smoking 10 or more cigarettes per day
  • diagnosed with and completed an initial course of treatment for any type of head and neck cancer
  • life expectancy of 12 months or more

Exclusion Criteria:

  • history of allergic reactions to adhesives
  • unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
  • females of childbearing potential who are pregnant, nursing, or not practicing effective contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00931021
Other Study ID Numbers  ICMJE 0903004910
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin Toll, Ph.D. Yale University
PRS Account Yale University
Verification Date July 2013

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