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Clinical Trials/NCT01635075
NCT01635075
Completed
Phase 2

Acute Effects of Exercise in Smokers With Schizophrenia

Brown University1 site in 1 country30 target enrollmentJune 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tobacco Dependence
Sponsor
Brown University
Enrollment
30
Locations
1
Primary Endpoint
Cigarette craving
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Tidey

Associate Professor (Research)

Brown University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Cigarette craving

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

Questionnaire on Smoking Urges - Brief form

Secondary Outcomes

  • Mood(within 10 minutes before and after exercise (or control activity))
  • Smoking habit withdrawal(within 10 minutes before and after exercise (or control activity))
  • Smoking choice(initiated 10 minutes after exercise (or control activity))

Study Sites (1)

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