Smoking Cessation Treatment for Head and Neck Cancer Patients

Yale University

Status and phase: Terminated; Early Phase 1

Conditions: Smoking Cessation

Treatments: Drug: Varenicline (Chantix); Drug: Nicotine Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00931021

0903004910

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Varenicline (Chantix)

Active Comparator group

Treatment:

Drug: Varenicline (Chantix)

Nicotine Patch

Active Comparator group

Treatment:

Drug: Nicotine Patch