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Completed

NCT Number: NCT02086149

Exercise for Depressed Smokers

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • are between 18 and 65 years of age
  • are current smokers (i.e., smoking at least 10 cigarettes per day)
  • have currently elevated depressive symptoms (CES-D ≥ 6)
  • 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

  • DSM-IV diagnosis of current mania
  • DSM-IV diagnosis of bipolar rapid cycling
  • lifetime history of psychotic disorder or DSM-IV diagnosis of current psychotic symptoms
  • DSM-IV diagnosis of current substance abuse or dependence in the past 6 months
  • DSM-IV diagnosis of anorexia or bulimia nervosa
  • current suicidality or homicidality
  • marked organic impairment
  • current use of antidepressant medication for less than 3 months or change in antidepressant medication or dosage in the past 3 months,
  • physical disabilities or medical problems that would prevent or hinder participation in a program of moderate intensity exercise (i.e., physician denied medical clearance)
  • current pregnancy or intent to become pregnant during the next 12 weeks
  • 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)
  • current illness or medications that may alter proposed inflammatory markers (e.g., acute infection, immune disorders, aspirin)
  • current use of any pharmacotherapy or other treatment for smoking cessation.

Treatment and study plan

Aerobic Exercise

Behavioral

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

Behavioral

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 outcomes

  1. Smoking Cessation

    Time frame: 1 year

    Abstinence from smoking verified biochemically (saliva cotinine)

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Aerobic Exercise for Smokers With Depressive Symptomatology

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2014
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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