Smoking Cessation Treatment for Head and Neck Cancer Patients
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jul 2009
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJuly 15, 2013
July 1, 2013
3.4 years
June 29, 2009
July 12, 2013
Conditions
Outcome Measures
Primary Outcomes (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.
Eight weeks
Secondary Outcomes (3)
To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer.
Eight weeks
To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.
Eight weeks
To examine the effect of varenicline and nicotine patch on alcohol consumption.
Eight weeks
Study Arms (2)
Varenicline (Chantix)
ACTIVE COMPARATORNicotine Patch
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Toll, Ph.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
July 2, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
July 15, 2013
Record last verified: 2013-07