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Smoking Cessation Treatment for Head and Neck Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00931021
First received: June 29, 2009
Last updated: July 1, 2009
Last verified: July 2009
History of Changes
  Purpose

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 Intervention Phase
Smoking Cessation
 Drug: Varenicline (Chantix)
Drug: Nicotine Patch
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Smoking Cessation Treatment for Head and Neck Cancer Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation. [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
  • To examine the effect of varenicline and nicotine patch on alcohol consumption. [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Varenicline (Chantix) Drug: Varenicline (Chantix)
2 mg
Other Name: Chanitx
Active Comparator: Nicotine Patch Drug: Nicotine Patch
21 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931021

Contacts
Contact: Benjamin Toll, Ph.D. 203-974-5767 benjamin.toll@yale.edu
Contact: Susan Neveu 203-974-5768 susan.neveu@yale.edu

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

No publications provided

Responsible Party: Benjamin Toll, Ph.D., Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00931021     History of Changes
Other Study ID Numbers: 0903004910
Study First Received: June 29, 2009
Last Updated: July 1, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Smoking
Neoplasms by Site
Neoplasms
Habits
Nicotine
Nicotine polacrilex
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013