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NCT01635075 · ClinicalTrials.gov registry record · Phase 2
Acute Effects of Exercise in Smokers With Schizophrenia
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01635075 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 30 participants.
The verdict
NCT01635075, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Exercise
- BEHAVIORAL passive control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01635075
The ClinicalTrials.gov registry entry for NCT01635075 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Exercise is the first listed.
NCT01635075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01635075 about?
NCT01635075 is a clinical study titled "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...
What is the current status of trial NCT01635075?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-06. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01635075?
The interventions under investigation include: Exercise (BEHAVIORAL), passive control (BEHAVIORAL).
Who is sponsoring clinical trial NCT01635075?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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