Behavioral Exercise Intervention for Smoking Cessation

Nicotine Dependence Clinical Trial

Official title:

Behavioral Exercise Intervention for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713063
• Other study ID #: 0603-01
• Secondary ID: 5K23DA019950
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2008
• Last updated: January 29, 2015
• Start date: April 2006
• Est. completion date: March 2012

Study information

• Verified date: January 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence

Intervention

Behavioral:
• aerobic exercise
12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch)
• Health Education Control
12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported smoking abstinence via Timeline Followback (TLFB)		12-months	No
Primary	Biochemically verified smoking abstinence via carbon monoxide and saliva cotinine		12 Months	No