Behavioral Exercise Intervention for Smoking Cessation

NCT00713063 | Completed Phase 2

• 2 other identifiers: 0603-015K23DA019950
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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

Keywords

smoking cessation; exercise; physical activity; health education

Outcome Measures

Primary Outcomes (2)

• Self-reported smoking abstinence via Timeline Followback (TLFB)

  12-months

• Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine

  12 Months

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: aerobic exercise

2

ACTIVE COMPARATOR

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

Behavioral: Health Education Control

Interventions

aerobic exercise BEHAVIORAL

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

1

Health Education Control BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Motor Activity; Health Education

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana Abrantes, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 11, 2008
• Study Start: April 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 30, 2015

Record last verified: 2015-01