Smoking Cessation Treatment for Head and Neck Cancer Patients

Early Phase 1

Terminated

• Conditions: Smoking Cessation
• Interventions: Drug: Varenicline (Chantix); Drug: Nicotine Patch

• Registration Number: NCT00931021
• Lead Sponsor: Yale University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-30
• Study Start: 2009-07
• Study First Posted: 2009-07-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-12
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline (Chantix)	Varenicline (Chantix)	-
Nicotine Patch	Nicotine Patch	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States