Acute Effects of Exercise in Smokers With Schizophrenia
Primary Purpose
Tobacco Dependence, Cigarette Craving, Smoking Behavior
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise
passive control
Sponsored by
About this trial
This is an interventional basic science trial for Tobacco Dependence focused on measuring psychiatric, comorbidity, craving, tobacco
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
Sites / Locations
- Brown University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Passive
Arm Description
1-mile treadmill walk
20 min inactivity
Outcomes
Primary Outcome Measures
Cigarette craving
Questionnaire on Smoking Urges - Brief form
Secondary Outcome Measures
Mood
Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.
Smoking habit withdrawal
Questionnaire measures of withdrawal from sensorimotor aspects of smoking
Smoking choice
2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01635075
Brief Title
Acute Effects of Exercise in Smokers With Schizophrenia
Official Title
Acute Effects of Exercise in Smokers With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Cigarette Craving, Smoking Behavior
Keywords
psychiatric, comorbidity, craving, tobacco
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
1-mile treadmill walk
Arm Title
Passive
Arm Type
Placebo Comparator
Arm Description
20 min inactivity
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
1-mile treadmill walk
Intervention Type
Behavioral
Intervention Name(s)
passive control
Intervention Description
20 min inactivity
Primary Outcome Measure Information:
Title
Cigarette craving
Description
Questionnaire on Smoking Urges - Brief form
Time Frame
within 10 minutes before and after exercise (or control activity)
Secondary Outcome Measure Information:
Title
Mood
Description
Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.
Time Frame
within 10 minutes before and after exercise (or control activity)
Title
Smoking habit withdrawal
Description
Questionnaire measures of withdrawal from sensorimotor aspects of smoking
Time Frame
within 10 minutes before and after exercise (or control activity)
Title
Smoking choice
Description
2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash.
Time Frame
initiated 10 minutes after exercise (or control activity)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Tidey, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
12. IPD Sharing Statement
Links:
URL
http://research.brown.edu/research/profile.php?id=1100925335
Description
Research site
Learn more about this trial
Acute Effects of Exercise in Smokers With Schizophrenia
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