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Behavioral Exercise Intervention for Smoking Cessation

Behavioral Exercise Intervention for Smoking Cessation

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00713063
Enrollment
61
Registered
2008-07-11
Start date
2006-04-30
Completion date
2012-03-31
Last updated
2015-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

smoking cessation, exercise, physical activity, health education

Brief summary

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.

Interventions

BEHAVIORALaerobic exercise

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

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Self-reported smoking abstinence via Timeline Followback (TLFB)12-months
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine12 Months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026