Measuring Smoking Behavior in People With Schizophrenia and Bipolar Disorder

NCT00382915 | Completed

• 2 other identifiers: R01MH076672DAHBR 96-BHB
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Smoking; Topography; Nicotine

Outcome Measures

Primary Outcomes (1)

• Smoking behavior and nicotine levels in those diagnosed with schizophrenia, those diagnosed with bipolar disorder and, those without a current mental illness

  Measured at Hour 24

Secondary Outcomes (1)

• Difference in blood levels of cotinine in smokers with schizophrenia compared to controls

  Measured at Hour 24

Study Arms (3)

1

Smokers with schizophrenia

Device: CReSSmicro handheld topography device

2

Smokers with bipolar disorder

Device: CReSSmicro handheld topography device

3

Smokers without any mental illness

Device: CReSSmicro handheld topography device

Interventions

CReSSmicro handheld topography device 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.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UMDNJ-Robert Wood Johnson Medical School, Department of Psychiatry, Division of Addictions

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (3)

• Williams JM, Gandhi KK, Lu SE, Kumar S, Steinberg ML, Cottler B, Benowitz NL. Shorter interpuff interval is associated with higher nicotine intake in smokers with schizophrenia. Drug Alcohol Depend. 2011 Nov 1;118(2-3):313-9. doi: 10.1016/j.drugalcdep.2011.04.009. Epub 2011 May 18.

  PMID: 21596491 RESULT

• Williams JM, Gandhi KK, Benowitz NL. Carbamazepine but not valproate induces CYP2A6 activity in smokers with mental illness. Cancer Epidemiol Biomarkers Prev. 2010 Oct;19(10):2582-9. doi: 10.1158/1055-9965.EPI-10-0384. Epub 2010 Aug 18.

  PMID: 20719908 RESULT

• Williams JM, Gandhi KK, Lu SE, Kumar S, Shen J, Foulds J, Kipen H, Benowitz NL. Higher nicotine levels in schizophrenia compared with controls after smoking a single cigarette. Nicotine Tob Res. 2010 Aug;12(8):855-9. doi: 10.1093/ntr/ntq102. Epub 2010 Jun 28.

  PMID: 20584771 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for DNA extraction

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Smoking

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Study Officials

• Jill M. Williams, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Kunal K. Gandhi, MBBS, MPH

  Rutgers, The State University of New Jersey

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 2, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

US (1)