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Exercise or Relaxation for Smoking Cessation

U

UConn Health

Status

Completed

Conditions

Nicotine Dependence
Smoking Cessation

Treatments

Behavioral: Exercise or relaxation treatment
Other: Varenicline and smoking cessation counseling

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00921388
1R01DA024872-01A1 (U.S. NIH Grant/Contract)
09-097-2

Details and patient eligibility

About

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.

Full 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)

Enrollment

301 patients

Sex

Female

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

301 participants in 2 patient groups

1
Experimental group
Description:
Exercise program
Treatment:
Behavioral: Exercise or relaxation treatment
Other: Varenicline and smoking cessation counseling
2
Other group
Description:
Relaxation program
Treatment:
Other: Varenicline and smoking cessation counseling

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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