Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00382915

Purpose

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
Schizophrenia Bipolar Disorder	Device: CReSSmicro handheld topography device

MedlinePlus related topics: Bipolar Disorder Mental Health Schizophrenia Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Nicotine Intake in Smokers With Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Difference in blood levels of cotinine in smokers with schizophrenia compared to controls [ Time Frame: Measured at Hour 24 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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
1 Smokers with schizophrenia	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.
2 Smokers with bipolar disorder	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.
3 Smokers without any mental illness	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

Inclusion Criteria:

For smokers with schizophrenia or bipolar disorder:

Meets DSM-IV diagnostic criteria for schizophrenia or bipolar I disorder
Smokes 10 or more cigarettes every day
Has been stable on current psychiatric medications for at least 1 month prior to study entry

For control smokers without mental illness:

Smokes 10 or more cigarettes every day

Exclusion Criteria:

For smokers with schizophrenia or bipolar disorder:

Current or past suicidal ideation, behavior, or suicide attempt within 30 days prior to study entry
Psychiatric hospitalization within 30 days prior to study entry
Inability to read English or inability to sufficiently understand study documents written in English
Pregnant, breastfeeding, or plans to become pregnant within 1 month of study entry
Current use of any non-cigarette forms of tobacco (e.g., cigars, pipes, smokeless tobacco, or ultralight cigarettes)
Current substance abuse problem, as defined by DAST or AUDIT criteria
Significant cognitive impairment that may interfere with study participation, as defined by a Folstein Mini-Mental Status exam score of less than 22

For control smokers without mental illness:

Any DSM-defined mental disorder within 1 year prior to study entry
Inability to read English or inability to sufficiently understand study documents written in English
Concomitant use of nicotine replacement therapy (e.g., gum, patch, inhaler, nasal spray, or lozenge), clonidine, bupropion, or nortriptyline
Pregnant, breastfeeding, or plans to become pregnant within 1 month of study entry
Current use of any non-cigarette forms of tobacco (e.g., cigars, pipes, smokeless tobacco, or ultralight cigarettes)
Diagnosis or treatment for an episode of any mental disorder (e.g., depression or anxiety) within 1 year prior to study entry
Lifetime diagnosis of bipolar disorder or schizophrenia
Lifetime history of any psychotic symptoms
Lifetime use of antipsychotic medication for any reason
Use of any antidepressants, mood stabilizers, or anti-anxiety medications for any reason within 6 months prior to study entry
Current substance abuse problem, as defined by DAST or AUDIT criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382915

Contacts

Contact: Kunal K. Gandhi, MBBS, MPH	732-235-4341	gandhiku@umdnj.edu
Contact: Jill M. Williams, MD	732-235-4341	jill.williams@umdnj.edu

Locations

United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School, Department of Psychiatry, Division of Addictions	Recruiting
New Brunswick, New Jersey, United States, 08901

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

More Information

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

Keywords provided by National Institute of Mental Health (NIMH):

Smoking
Topography
Nicotine

Study placed in the following topic categories:

Nicotine polacrilex
Schizophrenia
Smoking
Affective Disorders, Psychotic
Nicotine

Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009