Exercise or Relaxation for Smoking Cessation

NCT ID: NCT00921388

Last Updated: 2017-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2017-08-29

Brief 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.

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)

Conditions

Nicotine Dependence; Smoking Cessation

Keywords

Smoking Cessation; Exercise; Postmenopausal women; CHANTIX; varenicline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Exercise program

Group Type: EXPERIMENTAL

Varenicline and smoking cessation counseling

Intervention Type: 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.

Exercise or relaxation treatment

Intervention Type: 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.

2

Relaxation program

Group Type: OTHER

Varenicline and smoking cessation counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CHANTIX; exercise program

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl A Oncken, MD MPH

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

University of Connecticut Health Center

Farmington, Connecticut, United States

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

Reference Type: DERIVED

PMID: 34611902 (View on PubMed)

Other Identifiers

1R01DA024872-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-097-2

Identifier Type: -

Identifier Source: org_study_id