Exercise or Relaxation for Smoking Cessation
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ClinicalTrials.gov Identifier: NCT00921388 |
Recruitment Status :
Completed
First Posted : June 16, 2009
Last Update Posted : October 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nicotine Dependence Smoking Cessation | Other: Varenicline and smoking cessation counseling Behavioral: Exercise or relaxation treatment | Not Applicable |
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)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 301 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Exercise for Smoking Cessation in Postmenopausal Women |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | August 29, 2017 |
Actual Study Completion Date : | August 29, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Exercise program
|
Other: Varenicline and smoking cessation counseling
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.
Other Name: CHANTIX Behavioral: Exercise or relaxation treatment 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.
Other Name: exercise program |
2
Relaxation program
|
Other: Varenicline and smoking cessation counseling
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.
Other Name: CHANTIX |
- 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. [ Time Frame: Week 12 and Week 64 ]
- To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment. [ Time Frame: Week 12 and Week 64 ]

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921388
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Cheryl A Oncken, MD MPH | UConn Health |
Responsible Party: | UConn Health |
ClinicalTrials.gov Identifier: | NCT00921388 |
Other Study ID Numbers: |
09-097-2 1R01DA024872-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | June 16, 2009 Key Record Dates |
Last Update Posted: | October 31, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Smoking Cessation Exercise Postmenopausal women CHANTIX varenicline |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Varenicline Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |