Exercise or Relaxation for Smoking Cessation

• ClinicalTrials.gov Identifier: NCT00921388
• Recruitment Status: Completed
• First Posted: June 16, 2009
• Last Update Posted: October 31, 2017
• Sponsor: UConn Health
• Collaborators: National Institutes of Health (NIH); National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): UConn Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nicotine Dependence; Smoking Cessation	Other: Varenicline and smoking cessation counseling; Behavioral: Exercise or relaxation treatment	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 301 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exercise for Smoking Cessation in Postmenopausal Women
• Study Start Date: March 2009
• Actual Primary Completion Date: August 29, 2017
• Actual Study Completion Date: August 29, 2017

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes 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

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

UConn Health

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Cheryl A Oncken, MD MPH; UConn Health

More Information

• Responsible Party: UConn Health
• ClinicalTrials.gov Identifier: NCT00921388
• Other Study ID Numbers: 09-097-2; 1R01DA024872-01A1 ( U.S. NIH Grant/Contract )
• First Posted: June 16, 2009
• Last Update Posted: October 31, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by UConn Health:

Smoking Cessation; Exercise; Postmenopausal women; CHANTIX; varenicline

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs