Exercise or Relaxation for Smoking Cessation

This study is currently recruiting participants.
Verified November 2012 by University of Connecticut Health Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00921388
First received: June 15, 2009
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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 Intervention
Nicotine Dependence
Smoking Cessation
Other: Varenicline and smoking cessation counseling
Behavioral: Exercise or relaxation treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exercise for Smoking Cessation in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the main and interactive effects of history of depression and exercise on smoking cessation treatment. [ Time Frame: Week 12 and Week 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 364
Study Start Date: March 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921388

Contacts
Contact: Jennifer Brindisi, M.A. 860-679-4219 brindisi@uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jennifer Brindisi    860-679-3136    brindisi@uchc.edu   
Principal Investigator: Cheryl Oncken, MD, MPH         
Sub-Investigator: Anne M Kenny, M.D.         
Sub-Investigator: Mark D Litt, Ph.D         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kat Harrison, MPH    612-624-5439    harr0644@umn.edu   
Principal Investigator: Sharon S Allen, M.D., Ph.D         
Sub-Investigator: Harry Lando, Ph.D         
Sub-Investigator: John Sirard, Ph.D         
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Cheryl A Oncken, MD MPH University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00921388     History of Changes
Other Study ID Numbers: 09-097-2, 1RO1 DA024872-01A1
Study First Received: June 15, 2009
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Smoking Cessation
Exercise
Postmenopausal women
CHANTIX
varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014