Exercise or Relaxation for Smoking Cessation

NCT00921388 | Completed DMC

• 2 other identifiers: 09-097-21R01DA024872-01A1
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 2

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.

Conditions

Nicotine Dependence; Smoking Cessation

Keywords

Smoking Cessation; Exercise; Postmenopausal women; CHANTIX; varenicline

Outcome Measures

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.

  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.

  Week 12 and Week 64

Study Arms (2)

1

EXPERIMENTAL

Exercise program

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

2

OTHER

Relaxation program

Other: Varenicline and smoking cessation counseling

Interventions

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.

Also known as: CHANTIX

1; 2

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.

Also known as: exercise program

1

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Motor Activity

Interventions

Varenicline; Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Cheryl A Oncken, MD MPH

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: March 1, 2009
• Primary Completion: August 29, 2017
• Study Completion: August 29, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)