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Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2

This study has been completed.

Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00135772
  Purpose

Nicotine dependence is very common among individuals with schizophrenia and schizoaffective disorder. Cotinine is a chemical that is made by the body from nicotine. Measuring levels of nicotine and cotinine is an accurate way to determine how much cigarette smoke enters a person's body. The purpose of this study is to measure nicotine and cotinine levels in smokers with schizophrenia or schizoaffective disorder to determine if such individuals absorb more nicotine per cigarette than smokers without schizophrenia-related disorders.


Condition
Schizophrenia and Disorders With Psychotic Features
Tobacco Use Disorder

MedlinePlus related topics:   Psychotic Disorders    Schizophrenia   

ChemIDplus related topics:   Nicotine polacrilex    Nicotine tartrate    Cotinine   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder

Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment:   100
Study Start Date:   October 2003
Study Completion Date:   July 2004
Primary Completion Date:   July 2004 (Final data collection date for primary outcome measure)

Detailed Description:

Schizophrenic individuals have higher urinary cotinine levels compared to non-schizophrenic individuals with a similar smoking history. This suggests that schizophrenic individuals may absorb higher doses of nicotine. The purpose of this study is to determine whether smokers with schizophrenia or schizoaffective disorder have higher serum nicotine and cotinine levels in comparison to smokers without schizophrenic-related disorders.

This observational, case-control study will enroll 150 participants, of which 100 will be smokers with schizophrenic-related disorders and 50 will be smokers without a mental illness. Upon completing baseline assessments, participants will smoke a single cigarette. Approximately two minutes following, 3 to 4 ounces of blood will be analyzed for nicotine and cotinine levels. An expired carbon monoxide reading will also be measured. This measurement correlates with the amount of smoke inhalation. Individual participant studies will be completed in 1 to 2 hour-long sessions.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnostic criteria for nicotine dependence and possibly schizophrenia or schizoaffective disorder
  • Stable on current antipsychotic regimen(s) for participants with schizophrenia or schizoaffective disorder

Exclusion Criteria:

  • At serious risk of suicide, including recent suicidal behavior or attempt within the thirty days prior to study entry
  • Current use of clonidine, bupropion, or any other nicotine products (including nicotine patch, gum, inhaler, lozenge or nasal spray)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135772

Locations
United States, New Jersey
UMDNJ - Robert Wood Johnson Medical School    
      Piscataway, New Jersey, United States, 08854

Sponsors and Collaborators

Investigators
Principal Investigator:     Jill M. Williams, M.D.     University of Medicine and Dentistry New Jersey    
  More Information


Publications of Results:

Responsible Party:   UMDNJ-Robert Wood Johnson Medical School ( Jill Williams )
Study ID Numbers:   NIDA-14009-2, K23-14009-2, DPMC
First Received:   August 23, 2005
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00135772
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Nicotine polacrilex
Schizophrenia
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 17, 2008




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