Smoking Cessation Treatment for Head and Neck Cancer Patients
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...
Brief Summary
Official Title: “Smoking Cessation Treatment for Head and Neck Cancer Patients”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: July 2011
Intervention(s) in this Clinical Trial
- Drug: Varenicline (Chantix)
- 2 mg
- Drug: Nicotine Patch
- 21 mg
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Varenicline (Chantix)
- Active Comparator: Nicotine Patch
Outcome Measures for this Clinical Trial
Primary 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.
- Time Frame: Eight weeks
Safety Issue?: No
- Time Frame: Eight weeks
Secondary 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.
- Time Frame: Eight weeks
Safety Issue?: No
- Time Frame: Eight weeks
- To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.
- Time Frame: Eight weeks
Safety Issue?: No
- Time Frame: Eight weeks
- To examine the effect of varenicline and nicotine patch on alcohol consumption.
- Time Frame: Eight weeks
Safety Issue?: No
- Time Frame: Eight weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Yale University Other
Overall Clinical Trial Officials and Contacts
Benjamin Toll, Ph.D. Principal Investigator Yale University
Overall Contact: Benjamin Toll, Ph.D. 203-974-5767 benjamin.toll@yale.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931021
Study ID Number: 0903004910
ClinicalTrials.gov Identifier: NCT00931021
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00931021
