Smoking Cessation Treatment for Head and Neck Cancer Patients

Smoking Cessation Clinical Trial

Official title:

Smoking Cessation Treatment for Head and Neck Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00931021
• Other study ID #: 0903004910
• Status: Terminated
• Phase: Phase 0
• First received: June 29, 2009
• Last updated: July 12, 2013
• Start date: July 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Smoking Cessation

Intervention

Drug:
• Varenicline (Chantix)
2 mg
• Nicotine Patch
21 mg

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.		Eight weeks	No
Secondary	To examine the effect of varenicline and nicotine patch on alcohol consumption.		Eight weeks	No