Behavioral Exercise Intervention for Smoking Cessation

January 29, 2015 updated by: Butler Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
Behavioral: aerobic exercise
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
Active Comparator: 2
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
Behavioral: Health Education Control
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported smoking abstinence via Timeline Followback (TLFB)
Time Frame: 12-months
12-months
Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603-01
  • 5K23DA019950 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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