NCT00135772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

Enrollment Period

9 months

First QC Date

August 23, 2005

Last Update Submit

January 11, 2017

Conditions

Schizophrenia and Disorders With Psychotic FeaturesTobacco Use Disorder

Keywords

nicotine dependence

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ - Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

Related Publications (2)

  • 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.

    PMID: 15961287RESULT

  • 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.

    PMID: 17654300RESULT

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersTobacco Use Disorder

Condition Hierarchy (Ancestors)

Mental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Jill M. Williams, M.D.

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 26, 2005

Study Start

October 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(1)