Exercise or Relaxation for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Exercise for Smoking Cessation in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921388
• Other study ID #: 09-097-2
• Secondary ID: 1R01DA024872-01A
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: October 27, 2017
• Start date: March 2009
• Est. completion date: August 29, 2017

Study information

• Verified date: October 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: August 29, 2017
• Est. primary completion date: August 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking Cessation
• Tobacco Use Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment.		Week 12 and Week 64