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Completed

NCT Number: NCT01635075

Acute Effects of Exercise in Smokers With Schizophrenia

People with schizophrenia have two- to three-times the mortality risk of the general population. This is primarily due to their unusually high rates of cigarette smoking, as well as other cardiovascular risk factors such as physical inactivity, obesity, high blood cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and mortality in this population. Over a dozen experimental studies indicate that walking and other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on smoking measures have not been studied in smokers with schizophrenia. This study will use a within-subjects, repeated-measures design, in which participants will undergo 4 laboratory sessions (order counterbalanced across participants): (1) smoking cues followed by exercise, (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4) neutral cues followed by passive activity. Outcome measures include cigarette craving, nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the next step in this research would be to test the effectiveness of a smoking cessation intervention that incorporates exercise bouts as a behavioral strategy for improving smoking cessation rates in this population.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of schizophrenia
  • smoke at least 20 cigarettes per day
  • less than 60 min moderate-intensity exercise per week

Exclusion criteria

  • medication changes in past 4 weeks
  • unable to give informed consent to participate
  • alcohol/drug screen
  • pregnant or nursing
  • receiving or seeking immediate smoking treatment

Treatment and study plan

Exercise

Behavioral

1-mile treadmill walk

passive control

Behavioral

20 min inactivity

Primary outcomes

  1. Cigarette craving

    Time frame: within 10 minutes before and after exercise (or control activity)

    Questionnaire on Smoking Urges - Brief form

Secondary outcomes

  1. Mood

    Time frame: within 10 minutes before and after exercise (or control activity)

    Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.

  2. Smoking habit withdrawal

    Time frame: within 10 minutes before and after exercise (or control activity)

    Questionnaire measures of withdrawal from sensorimotor aspects of smoking

  3. Smoking choice

    Time frame: initiated 10 minutes after exercise (or control activity)

    2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 6, 2012
Registry last updated
Sep 28, 2015

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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