Smoking Cessation Treatment for Head and Neck Cancer Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00931021
First received: June 29, 2009
Last updated: July 12, 2013
Last verified: July 2013
  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:


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 ]

Enrollment: 7
Study Start Date: July 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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

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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00931021     History of Changes
Other Study ID Numbers: 0903004910
Study First Received: June 29, 2009
Last Updated: July 12, 2013
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 April 22, 2014