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Smoking Cessation Treatment for Head and Neck Cancer Patients


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Smoking Cessation

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Trial Information

Smoking Cessation Treatment for Head and Neck Cancer Patients


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Eight weeks

Safety Issue:

No

Principal Investigator

Benjamin Toll, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

0903004910

NCT ID:

NCT00931021

Start Date:

July 2009

Completion Date:

July 2011

Related Keywords:

  • Smoking Cessation
  • Head and Neck Neoplasms
  • Smoking

Name

Location

Yale University School Of MedicineNew Haven, Connecticut  06520