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Smoking Cessation Treatment for Head and Neck Cancer Patients

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ClinicalTrials.gov Identifier: NCT00931021
Recruitment Status : Terminated
First Posted : July 2, 2009
Last Update Posted : July 15, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Varenicline (Chantix) Drug: Nicotine Patch Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking Cessation Treatment for Head and Neck Cancer Patients
Study Start Date : July 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Varenicline
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Varenicline (Chantix) Drug: Varenicline (Chantix)
2 mg
Other Name: Chanitx
Active Comparator: Nicotine Patch Drug: Nicotine Patch
21 mg

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. [ Time Frame: Eight weeks ]
  3. To examine the effect of varenicline and nicotine patch on alcohol consumption. [ Time Frame: Eight weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931021

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Principal Investigator: Benjamin Toll, Ph.D. Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00931021     History of Changes
Other Study ID Numbers: 0903004910
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action