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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00135772
First received: August 23, 2005
Last updated: August 19, 2008
Last verified: August 2008
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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. Rutgers, The State University of 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
Chemically-Induced 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 August 01, 2014