Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00382915
• Date of registration: 29/09/2006
• Primary sponsor: National Institute of Mental Health (NIMH)
• Public title: Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder
• Scientific title: Nicotine Intake in Smokers With Schizophrenia
• Date of first enrolment: October 2006
• Target sample size: 276
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00382915
• Study type: Observational
• Study design: Observational Model: Case Control, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Jill M. Williams, MD
• Affiliation: University of Medicine and Dentistry New Jersey

• Name: Kunal K. Gandhi, MBBS, MPH
• Affiliation: University of Medicine and Dentistry New Jersey

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bipolar Disorder

Schizophrenia

Intervention(s)

Device: CReSSmicro handheld topography device

Primary Outcome(s)

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]

Secondary Outcome(s)

Difference in blood levels of cotinine in smokers with schizophrenia compared to controls [Time Frame: Measured at Hour 24]

Secondary ID(s)

DAHBR 96-BHB

R01 MH076672

Source(s) of Monetary Support

Please refer to primary and secondary sponsors