Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00501007
First received: July 11, 2007
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The primary purpose of this investigation is to determine the predictive value of task persistence as measured by a mirror tracing task. A secondary purpose is to evaluate differences in task persistence in smokers with or without schizophrenia. It is hypothesized that task persistence in smokers in both diagnostic categories (schizophrenia and no schizophrenia) will predict tobacco dependence treatment outcome at one and six months. It is also hypothesized that smokers with schizophrenia will show lower levels of task persistence after controlling for other motor skills than smokers without schizophrenia.


Condition Phase
Tobacco Dependence
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Mirror-tracing Persistence (in Seconds) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Number of seconds participants continued working on a mirror tracing task before giving up.


Secondary Outcome Measures:
  • Persistence as a Prospective Predictor of Smoking Cessation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Analysis of Generalized Estimating Equations (GEE) parameter estimates based on empirical standard error estimates, using an exchangeable working correlation structure, with smoking abstinence as outcome variable, and task persistence, time, diagnosis, ability, Fagerstrom Test for Nicotine Dependence (FTND) score, and the interaction between disorder and persistence as explanatory variables.


Enrollment: 203
Study Start Date: February 2005
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-psychiatric smokers
Smokers not meeting criteria for Schizophrenia or Schizoaffective Disorder
Smokers with Schizophrenia
Smokers meeting criteria for schizophrenia or schizoaffective disorder

Detailed Description:

Please see brief summary above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals from mental health centers in Central New Jersey or non-psychiatric controls from the community

Criteria

Inclusion Criteria:

  • Current smokers must be over the age of 18,
  • Must fit into the diagnostic groups schizophrenia / schizoaffective disorder; or the non-schizophrenia group.
  • Must smoke at least 10 cigarettes per day
  • Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22.

Exclusion Criteria:

  • Those unable to give informed consent.
  • Psychotic disorders other than schizophrenia
  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: NCT00501007

Locations
United States, New Jersey
UMDNJ Tobacco Dependence Clinic
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Marc L. Steinberg, PH.D Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00501007     History of Changes
Other Study ID Numbers: K23 DA018203, K23DA018203
Study First Received: July 11, 2007
Results First Received: January 7, 2013
Last Updated: December 6, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Schizophrenia
Tobacco Use Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on August 26, 2014