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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nicotine Dependence Adherence Interventions Behavior Chemically-Induced Disorders Health Behavior Health Education Medication Adherence Mental Disorders Motor Activity Patient Acceptance of Health Care Patient Compliance Smoking Cessation Substance-Related Disorders Tobacco Use Disorder Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

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

Health Education Control

Behavioral

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

Primary outcomes

Self-reported smoking abstinence via Timeline Followback (TLFB)

Time frame: 12-months
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine

Time frame: 12 Months

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2012
First posted: Jul 11, 2008
Registry last updated: Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed