Exercise or Relaxation for Smoking Cessation - Full Text View

Purpose

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.

Condition	Intervention
Nicotine Dependence Smoking Cessation	Other: Varenicline and smoking cessation counseling Behavioral: Exercise or relaxation treatment


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Exercise for Smoking Cessation in Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment. [ Time Frame: Week 12 and Week 64 ] [ Designated as safety issue: No ]


Estimated Enrollment:	364
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Detailed Description:

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)

Eligibility


Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921388

Locations


United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Connecticut Health Center

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Cheryl A Oncken, MD MPH	University of Connecticut Health Center

More Information

No publications provided


Responsible Party:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00921388 History of Changes
Other Study ID Numbers:	09-097-2, 1RO1 DA024872-01A1
Study First Received:	June 15, 2009
Last Updated:	October 29, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:


Smoking Cessation Exercise Postmenopausal women CHANTIX varenicline

Additional relevant MeSH terms:


Varenicline Cholinergic Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents Nicotinic Agonists Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015