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Behavioral Exercise Intervention for Smoking Cessation

Primary Purpose

Nicotine Dependence

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

aerobic exercise

Health Education Control

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring smoking cessation, exercise, physical activity, health education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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).

Outcomes

Primary Outcome Measures

Self-reported smoking abstinence via Timeline Followback (TLFB)

Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine

Secondary Outcome Measures

Full Information

NCT ID

NCT00713063

First Posted

July 9, 2008

Last Updated

January 29, 2015

Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00713063

Brief Title

Behavioral Exercise Intervention for Smoking Cessation

Official Title

Behavioral Exercise Intervention for Smoking Cessation

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

smoking cessation, exercise, physical activity, health education

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

aerobic exercise

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Health Education Control

Intervention Description

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

Primary Outcome Measure Information:

Title

Self-reported smoking abstinence via Timeline Followback (TLFB)

Time Frame

12-months

Title

Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana Abrantes, PhD

Organizational Affiliation

Butler Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Behavioral Exercise Intervention for Smoking Cessation

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