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Exercise for Depressed Smokers

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ClinicalTrials.gov Identifier: NCT02086149
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Butler Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Tobacco Smoking Smoking Cessation Behavioral: Aerobic Exercise Behavioral: Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerobic Exercise for Smokers With Depressive Symptomatology
Actual Study Start Date : February 2014
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
12-week moderate-intensity behavioral exercise intervention (AE)
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.

Active Comparator: Health Education
12-week health education control
Behavioral: 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.




Primary Outcome Measures :
  1. Smoking Cessation [ Time Frame: 1 year ]
    Abstinence from smoking verified biochemically (saliva cotinine)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086149


Locations
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United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ana M. Abrantes, Ph.D. Butler Hospital
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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02086149    
Other Study ID Numbers: 1304-001
R01CA173551 ( U.S. NIH Grant/Contract )
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Keywords provided by Butler Hospital:
Quit smoking
Exercise
Tobacco
Smoking