Smoking Cessation
Conditions
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.
Interventions
2 mg
DRUGNicotine Patch
21 mg
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Eight weeks |
Secondary
| Measure | Time frame |
|---|---|
| To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer. | Eight weeks |
| To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. | Eight weeks |
| To examine the effect of varenicline and nicotine patch on alcohol consumption. | Eight weeks |
Countries
United States
Outcome results
None listed