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

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ClinicalTrials.gov Identifier: NCT00135772
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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 or disease
Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder

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.


Study Type : Observational
Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder
Study Start Date : October 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135772


Locations
United States, New Jersey
UMDNJ - Robert Wood Johnson Medical School
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Jill M. Williams, M.D. Rutgers, The State University of New Jersey

Publications of Results:
Responsible Party: Jill Williams, UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00135772     History of Changes
Other Study ID Numbers: NIDA-14009-2
K23-14009-2
DPMC
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine dependence

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Pathologic Processes
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action