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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00382915 |
This study will evaluate the differences in smoking behavior, nicotine intake, and nicotine boost among people with schizophrenia, bipolar disorder, or no mental illness.
Condition | Intervention |
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Schizophrenia Bipolar Disorder |
Device: CReSSmicro handheld topography device |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Nicotine Intake in Smokers With Schizophrenia |
Whole blood for DNA extraction
Estimated Enrollment: | 300 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Smokers with schizophrenia
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Device: CReSSmicro handheld topography device
The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
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2
Smokers with bipolar disorder
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Device: CReSSmicro handheld topography device
The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
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3
Smokers without any mental illness
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Device: CReSSmicro handheld topography device
The CReSS micro device represents the state-of-the-art technology for measurements of ambulatory puff topography taken in the smoker's natural environment. Although all topography measurements are limited, at least to some degree, by the artificial act of smoking while using a device, or smoking through a mouthpiece, this small, lightweight and portable device is easy to use outside of the laboratory setting to capture more naturalistic smoking behavior and allows for less intrusion from the research team and research environment.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects will be 100 smokers with schizophrenia, 100 smokers with bipolar disorder and 100 smokers without mental illness. This will include smokers within the New Jersey metropolitan area, who receive treatment at the UMDNJ-University Behavioral Health Care System (UBHC) or at another outpatient behavioral health care agency. A community sample of healthy volunteer smokers without mental illness will be recruited through advertisements to participate in the study.
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:
Contact: Kunal K. Gandhi, MBBS, MPH | 732-235-4341 | gandhiku@umdnj.edu |
Contact: Jill M. Williams, MD | 732-235-4341 | jill.williams@umdnj.edu |
United States, New Jersey | |
UMDNJ-Robert Wood Johnson Medical School, Department of Psychiatry, Division of Addictions | Recruiting |
New Brunswick, New Jersey, United States, 08901 |
Principal Investigator: | Jill M. Williams, MD | University of Medicine and Dentistry New Jersey |
Study Director: | Kunal K. Gandhi, MBBS, MPH | University of Medicine and Dentistry New Jersey |
Responsible Party: | UMDNJ - Robert Wood Johnson Medical School ( Jill M Williams, MD ) |
Study ID Numbers: | R01 MH76672, DAHBR 96-BHB |
Study First Received: | September 29, 2006 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00382915 |
Health Authority: | United States: Federal Government |
Smoking Topography Nicotine |
Nicotine polacrilex Schizophrenia Smoking Affective Disorders, Psychotic Nicotine |
Mental Disorders Bipolar Disorder Mood Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Pathologic Processes Disease |