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Behavioral Exercise Intervention for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00713063
First received: July 9, 2008
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.


Condition Intervention Phase
Nicotine Dependence
 Behavioral: aerobic exercise
Behavioral: Health Education Control
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Self-reported smoking abstinence via Timeline Followback (TLFB) [ Time Frame: 12-months ] [ Designated as safety issue: No ]
  • Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: April 2006
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
 Behavioral: aerobic exercise
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
Active Comparator: 2
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
 Behavioral: Health Education Control
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are between 18 and 65 years of age
  2. are current smokers (i.e., smoking at least 10 cigarettes per day)
  3. are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.

Exclusion Criteria:

  1. current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
  2. Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
  3. lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
  4. lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
  5. current suicidality or homicidality
  6. marked organic impairment
  7. physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise
  8. current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713063

Sponsors and Collaborators
Butler Hospital
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ana Abrantes, PhD Butler Hospital
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00713063     History of Changes
Other Study ID Numbers: 0603-01, 5K23DA19950
Study First Received: July 9, 2008
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
smoking cessation
exercise
physical activity
health education

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Substance-Related Disorders
Mental Disorders
Habits

ClinicalTrials.gov processed this record on May 22, 2013