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Completed

NCT Number: NCT00921388

Exercise or Relaxation for Smoking Cessation

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Motor Activity Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center, Farmington, Connecticut, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline and smoking cessation counseling

Other

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 names: CHANTIX

Exercise or relaxation treatment

Behavioral

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 names: exercise program

Primary outcomes

  1. 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

Secondary outcomes

  1. To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.

    Time frame: Week 12 and Week 64

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Exercise for Smoking Cessation in Postmenopausal Women

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2009
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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