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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 29, 2006 | ||||||||
| Last Updated Date | April 21, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Smoking behavior and nicotine levels in those diagnosed with schizophrenia, those diagnosed with bipolar disorder and, those without a current mental illness [ Time Frame: Measured at Hour 24 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00382915 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Difference in blood levels of cotinine in smokers with schizophrenia compared to controls [ Time Frame: Measured at Hour 24 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder | ||||||||
| Official Title ICMJE | Nicotine Intake in Smokers With Schizophrenia | ||||||||
| Brief Summary | This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine boost among people with schizophrenia, bipolar disorder, or no mental illness. |
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| Detailed Description | People with schizophrenia, a disabling mental disorder, smoke at rates three times higher than those of the general population. They also tend to develop serious medical problems due to this heavy smoking. Little is known, however, about the relationship between schizophrenia and smoking. Smoking topography, the study of cigarette-puffing behavior, may help to uncover important information about the smoking habits of people with schizophrenia, and how they differ from smokers who do not have a mental illness. To develop more effective treatment approaches for schizophrenic smokers, a better understanding of nicotine addiction in this population is needed. This study will use hand-held smoking topography devices and blood tests to measure smoking behavior and nicotine levels in people with schizophrenia. This information will be compared to similar measurements in people with no mental illness and in people with bipolar disorder, another disorder associated with high rates of heavy smoking. Participation in this open-label, observational study will last approximately 1 to 2 weeks, and will consist of two to three study visits. The first visit will last about 2 hours, and will include screening procedures, completion of baseline questionnaires, and a practice session of smoking topography. Subjects will return on a second day (Day 2) for the remainder of the study procedures to assess their smoking puffing behavior and nicotine intake from usual cigarette smoking, which will occur within 1 week of the Day 1 assessments. On the afternoon prior to Day 2 subjects will have a brief appointment to review instructions for using the topography device. They will take the topography with them and be instructed to use it as they smoke ad-lib that evening at home. This will serve as a second practice session for getting used to the topography device. They will also be instructed to use the device for all cigarettes smoked upon awakening the next day at 6am (Day 2), including the first cigarette of the day. They will go to the study site for the first of three blood tests at 9:30 A.M, after which they will be allowed to leave the study site to continue with their daily activities. They will use the smoking topography device throughout the day, until 3 P.M. At this time, study staff will go to each participant's location to collect the device. Participants will have two additional blood tests over the course of the study to measure nicotine levels. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Device: CReSSmicro handheld topography device | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: For smokers with schizophrenia or bipolar disorder:
For control smokers without mental illness:
Exclusion Criteria: For smokers with schizophrenia or bipolar disorder:
For control smokers without mental illness:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00382915 | ||||||||
| Responsible Party | Jill M. Williams, MD, UMDNJ - Robert Wood Johnson Medical School | ||||||||
| Study ID Numbers ICMJE | R01 MH076672, DAHBR 96-BHB | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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