Behavioral Exercise Intervention for Smoking Cessation

Butler Hospital

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence

Treatments: Behavioral: Health Education Control; Behavioral: aerobic exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00713063

5K23DA019950 (U.S. NIH Grant/Contract)

0603-01

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

1

Experimental group

Description:

12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)

Treatment:

Behavioral: aerobic exercise

2

Active Comparator group

Description:

12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).

Treatment:

Behavioral: Health Education Control