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Clinical Trial Details
Exercise for Smoking Cessation in Postmenopausal Women
Clinical Trial ( IRB ) #: 09-097-2
Title: Exercise for Smoking Cessation in Postmenopausal Women
Principal Investigator: Dr. Cheryl Oncken
Description: This prospective, randomized trial will be conducted at two sites, the University of Connecticut Health Center and the University of Minnesota. Three hundred and sixty-four postmenopausal women who are at least 45 years old and smoke at least 10 cigarettes per day will be recruited. The study will compare the addition of a moderate exercise program or relaxation time contact control as an adjunct to a comprehensive smoking treatment program that includes behavioral counseling and varenicline. Interactive voice response system (IVR) will be utilized to increase adherence to both treatment conditions. The main outcome of interest is the magnitude of the smoking cessation rates at the end of medication treatment and at one year.
Classification:
  Smoking
  Women’s Health (Infertility, Menopause, Etc.)
Eligibility Criteria: Inclusion Criteria: •Postmenopausal women at least 50 years of age •Smoking at least 10 cigarettes per day •Motivated to quit smoking •Ambulatory •Currently exercising for 90 minutes of moderate exercise or less per week •Motivated to exercise Exclusion Criteria: •Denied medical clearance from primary care provider •Unstable angina or uncompensated heart failure •Systolic blood pressure greater than 165 or diastolic blood pressure greater than 100 •Heart attack or stroke within the preceding 6 months •Hip fracture within the preceding 6 months •Unstable medical or psychiatric disorder (e.g., current major depressive disorder or substance abuse or dependence) •Exercise-exacerbated neuromuscular disorder •Treatment for depression within the last year •Estimated creatinine clearance of less than 30cc/minute •Current use of a smoking cessation aid (i.e., bupropion, NRT, clonidine) •Current use of psychotropic medication •Previous serious adverse event with Chantix use
How to Contact: Lynn McLaughlin. Telephone: (860) 679-4152. Email: Lmclaughlin@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.
Web Address: clinicaltrials.gov/ct2/show/NCT00921388?term=00921388&rank=1.