Smoking Cessation Treatment for Head and Neck Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Varenicline (Chantix)

Group Type ACTIVE_COMPARATOR

Varenicline (Chantix)

Intervention Type DRUG

2 mg

Nicotine Patch

Group Type ACTIVE_COMPARATOR

Nicotine Patch

Intervention Type DRUG

21 mg

Interventions

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Varenicline (Chantix)

2 mg

Intervention Type DRUG

Nicotine Patch

21 mg

Intervention Type DRUG

Other Intervention Names

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Chanitx

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No