Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Tobacco Dependence Clinical Trial

Official title:

Predictors of Treatment Outcome for Smokers With and Without Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501007
• Other study ID #: K23DA018203
• Secondary ID: K23DA018203
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: July 13, 2017
• Start date: February 2005
• Est. completion date: January 2013

Study information

• Verified date: July 2017
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Please see brief summary above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Dependence
• Tobacco Use Disorder

Locations

Country	Name	City	State
United States	UMDNJ Tobacco Dependence Clinic	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mirror-tracing Persistence (in Seconds)	Number of seconds participants continued working on a mirror tracing task before giving up.	baseline
Secondary	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