Exercise or Relaxation for Smoking Cessation

Study Overview
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Brief Summary
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This research study is being done to find out if adding a moderate exercise program or a relaxation program to a smoking cessation treatment program will improve smoking cessation and health in postmenopausal women. We hope to learn which group is more successful at quitting, has less symptoms of withdrawal from smoking and has improved health.

Detailed Description
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Prevalence of smoking among women has declined more slowly in women than among men. Women who quit smoking substantially reduce the risk of premature death. A multi-modal approach to smoking cessation with combined behavioral and pharmacological interventions generally yields the highest success rates. The majority of subjects who are able to achieve abstinence return to smoking. Smoking relapse rates are 50-80% within one year with the majority of smokers relapsing within the first 3 months. Interventions are needed to both enhance smoking cessation rates and prevent relapse rates in order to substantially impact long-term quit rates.We intend to compare the effectiveness of a smoking cessation program combined with a moderate exercise program to an identical smoking cessation program combined with a relaxation-meditation control condition. In a substudy, we will also evaluate the effectiveness of the intervention in premenopausal women (N=40)

Official Title
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Exercise for Smoking Cessation in Postmenopausal Women

Conditions
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Nicotine Dependence, Smoking Cessation

Intervention / Treatment
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* Other: Varenicline and smoking cessation counseling
* Behavioral: Exercise or relaxation treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women at least 45 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 Permission from Primary Care Provider Good general health 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 for a psychiatric problem Prescription narcotic abuse or dependence with the exception of people that have been stabilized on Methadone Maintenance or Suboxone Previous serious adverse event with Chantix use

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Exercise program | Other: Varenicline and smoking cessation counseling<br>* All subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program.<br>* Other names: CHANTIX;Behavioral: Exercise or relaxation treatment<br>* One hour exercise sessions twice a week for 8 weeks, then once a week for 8 weeks, then once every other week for 4 weeks. Subjects in the control group receive a relaxation program that controls for contact time.<br>* Other names: exercise program;|
| Other: 2<br>Relaxation program | Other: Varenicline and smoking cessation counseling<br>* All subjects receive smoking cessation counseling and varenicline 0.5mg daily for three days then twice a day for the next four days; then 1 mg twice a day for 11 weeks. Counseling is integrated within the exercise or relaxation treatment program.<br>* Other names: CHANTIX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether adding an established moderate resistance/aerobic exercise program for postmenopausal women 45 years of age and older to a standard smoking cessation treatment program improves short and long term smoking outcomes. |  | Week 12 and Week 64 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment. |  | Week 12 and Week 64 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Exercise, Postmenopausal women, CHANTIX, varenicline