Behavioral Exercise Intervention for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
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

July 9, 2008
July 31, 2012
April 2006
March 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00713063 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Behavioral Exercise Intervention for Smoking Cessation
Behavioral Exercise Intervention for Smoking Cessation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nicotine Dependence
  • Behavioral: aerobic exercise
    12-week moderate intensity behavioral exercise intervention (MIBE) 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).
  • Experimental: 1
    12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
    Intervention: Behavioral: aerobic exercise
  • Active Comparator: 2
    12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
    Intervention: Behavioral: Health Education Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00713063
0603-01, 5K23DA19950
No
Butler Hospital
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Ana Abrantes, PhD Butler Hospital
Butler Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP