Behavioral Exercise Intervention for Smoking Cessation

NCT ID: NCT00713063

Last Updated: 2015-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-03-31

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: BEHAVIORAL

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

2

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

Group Type: ACTIVE_COMPARATOR

Health Education Control

Intervention Type: BEHAVIORAL

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

Interventions

aerobic exercise

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

Intervention Type: BEHAVIORAL

Health Education Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Abrantes, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Other Identifiers

5K23DA019950

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0603-01

Identifier Type: -

Identifier Source: org_study_id