Status:
COMPLETED
Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
18-75 years
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.
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 smo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00382915
Start Date
October 1 2006
End Date
December 1 2010
Last Update
May 27 2013
Active Locations (1)
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1
UMDNJ-Robert Wood Johnson Medical School, Department of Psychiatry, Division of Addictions
New Brunswick, New Jersey, United States, 08901