Back to resultsSmoking Cessation Treatment for Head and Neck Cancer Patients
Primary Purpose
Smoking Cessation
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Varenicline (Chantix)
Nicotine Patch
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation
Eligibility Criteria
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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Varenicline (Chantix)
Nicotine Patch
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer.
To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.
To examine the effect of varenicline and nicotine patch on alcohol consumption.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00931021
Brief Title
Smoking Cessation Treatment for Head and Neck Cancer Patients
Official Title
Smoking Cessation Treatment for Head and Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varenicline (Chantix)
Arm Type
Active Comparator
Arm Title
Nicotine Patch
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Varenicline (Chantix)
Other Intervention Name(s)
Chanitx
Intervention Description
2 mg
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Intervention Description
21 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.
Time Frame
Eight weeks
Title
To examine the effect of varenicline and nicotine patch on alcohol consumption.
Time Frame
Eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Toll, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
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Smoking Cessation Treatment for Head and Neck Cancer Patients
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