Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder - 2
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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 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Nicotine and Cotinine Levels in Smokers With Schizophrenia and Schizoaffective Disorder |
| 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) |
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 |
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| United States, New Jersey | |
| UMDNJ - Robert Wood Johnson Medical School | |
| Piscataway, New Jersey, United States, 08854 | |
| Principal Investigator: | Jill M. Williams, M.D. | University of Medicine and Dentistry New Jersey |
More Information
Publications:
| 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 |
| Study First Received: | August 23, 2005 |
| Last Updated: | August 19, 2008 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Tobacco Use Disorder Schizophrenia and Disorders with Psychotic Features Substance-Related Disorders Nicotine Ganglionic Stimulants Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013