Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence

Detailed Description

Please see brief summary above.

• Study Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • UMDNJ Tobacco Dependence Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-psychiatric smokers; Smokers not meeting criteria for Schizophrenia or Schizoaffective Disorder
Smokers with Schizophrenia; Smokers meeting criteria for schizophrenia or schizoaffective disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mirror-tracing Persistence (in Seconds)	Number of seconds participants continued working on a mirror tracing task before giving up.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Persistence as a Prospective Predictor of Smoking Cessation	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.	6 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Marc L. Steinberg, PH.D, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 11, 2007
• First Submitted That Met QC Criteria: July 12, 2007
• First Posted (Estimate): July 13, 2007

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Tobacco Use Disorder
• Other Study ID Numbers: K23DA018203 (U.S. NIH Grant/Contract)