Behavioral Exercise Intervention for Smoking Cessation

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Exercise Intervention for Smoking Cessation

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: aerobic exercise
* Behavioral: Health Education Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are between 18 and 65 years of age are current smokers (i.e., smoking at least 10 cigarettes per day) 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: current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP Substance abuse or dependence (excluding nicotine dependence) within the past 6 months lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP current suicidality or homicidality marked organic impairment 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch) | Behavioral: aerobic exercise<br>* 12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)<br>|
| Active Comparator: 2<br>12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch). | Behavioral: Health Education Control<br>* 12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported smoking abstinence via Timeline Followback (TLFB) |  | 12-months | 
| Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, exercise, physical activity, health education