Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Observational

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.
    

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.
    

Intervention name(s): CReSSmicro handheld topography device
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Whole blood for DNA extraction
    
Keywords: Smoking; Topography; Nicotine