Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Completed

• Conditions: Tobacco Dependence

• Registration Number: NCT00501007
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

Detailed Description

Please see brief summary above.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Results First Submitted: 2013-01-07
• Results First Submitted QC: 2013-12-06
• Results First Posted: 2013-12-13
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Persistence as a Prospective Predictor of Smoking Cessation	6 months	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.

Trial Locations

Locations (1)

UMDNJ Tobacco Dependence Clinic; 🇺🇸 New Brunswick, New Jersey, United States