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

NCT ID: NCT00135772

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2004-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia and Disorders With Psychotic Features Tobacco Use Disorder

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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UMDNJ-Robert Wood Johnson Medical School

Principal Investigators

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Jill M. Williams, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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UMDNJ - Robert Wood Johnson Medical School

Piscataway, New Jersey, United States

Site Status

Countries

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United States

References

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Williams JM, Ziedonis DM, Abanyie F, Steinberg ML, Foulds J, Benowitz NL. Increased nicotine and cotinine levels in smokers with schizophrenia and schizoaffective disorder is not a metabolic effect. Schizophr Res. 2005 Nov 15;79(2-3):323-35. doi: 10.1016/j.schres.2005.04.016. Epub 2005 Jun 14.

Reference Type RESULT
PMID: 15961287 (View on PubMed)

Williams JM, Gandhi KK, Steinberg ML, Foulds J, Ziedonis DM, Benowitz NL. Higher nicotine and carbon monoxide levels in menthol cigarette smokers with and without schizophrenia. Nicotine Tob Res. 2007 Aug;9(8):873-81. doi: 10.1080/14622200701484995.

Reference Type RESULT
PMID: 17654300 (View on PubMed)

Other Identifiers

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K23-14009-2

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-14009-2

Identifier Type: -

Identifier Source: org_study_id

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