Exercise for Depressed Smokers

Smoking Cessation Clinical Trial

Official title:

Aerobic Exercise for Smokers With Depressive Symptomatology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086149
• Other study ID #: 1304-001
• Secondary ID: R01CA173551
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: February 2019

Study information

• Verified date: May 2019
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for helping individuals with elevated depressive symptoms to quit smoking. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in smoking cessation. The long-term goal of this program of research is to disseminate an effective, aerobic exercise (AE) intervention for smoking cessation that can be readily adopted by smokers with elevated depressive symptoms, including those with current major depressive disorder (MDD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• 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. have currently elevated depressive symptoms (CES-D = 6)

4. are sedentary, i.e., have not participated regularly in aerobic exercise (for at least 90 minutes per week during the past three months)

Exclusion Criteria:

1. DSM-IV diagnosis of current mania

2. DSM-IV diagnosis of bipolar rapid cycling

3. lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms

4. DSM-IV diagnosis of current substance abuse or dependence in the past 6 months

5. DSM-IV diagnosis of anorexia or bulimia nervosa

6. current suicidality or homicidality

7. marked organic impairment

8. current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,

9. physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)

10. current pregnancy or intent to become pregnant during the next 12 weeks

11. contraindications for use of the nicotine patch (e.g., pregnancy, recent myocardial infarction, arrhythmia, angina, untreated hypertension, untreated diabetes, and previous adverse reaction to the patch)

12. current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)

13. current use of any pharmacotherapy or other treatment for smoking cessation.

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Smoking

Intervention

Behavioral:
• Aerobic Exercise
12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. Two month course of the nicotine patch initiated during week 5.
• Health Education
12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	Abstinence from smoking verified biochemically (saliva cotinine)	1 year