Risk Perception in Drug-Dependent Adults With and Without Schizophrenia
|ClinicalTrials.gov Identifier: NCT01031563|
Recruitment Status : Completed
First Posted : December 14, 2009
Last Update Posted : July 2, 2017
|First Submitted Date||December 11, 2009|
|First Posted Date||December 14, 2009|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||August 18, 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01031563 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Risk Perception in Drug-Dependent Adults With and Without Schizophrenia|
|Official Title||Risk Perception in Drug-Dependent Adults With and Without Schizophrenia|
- To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Several studies of risk perception have demonstrated a common bias known as unrealistic optimism', in which individuals feel they are less likely than other people to experience unpleasant or harmful events in their lives, but more likely to experience pleasant or beneficial events. In a previous study, we showed that unrealistic optimism about adverse events in patients with schizophrenia was lower than in healthy controls.
To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Adults with current diagnosis (DSM-IV criteria) of schizophrenia or schizoaffective disorder (n = 24), with current drug dependence (cannabis or cocaine) (n = 24), with both schizophrenia and drug dependence (n = 24), or healthy, non-drug-using controls (n = 24).
Subjects will have a single study visit, at which their psychiatric and substance use histories, current substance use (urine drug testing, expired breath CO), risk perception, risk-taking/impulsivity, sensation-seeking, insight, history of risky behavior, and cognitive function will be assessed.
Scores on Risk Perception Questionnaire, Balloon Analog Risk Task, short form self-report assessments of risk perception, risk-taking/impulsivity and sensation-seeking, Revised Life Orientation Scale, Self-Mastery Scale, Zuckerman-Kuhlman Personality Questionnaire, Repeatable Battery for the Assessment of Neuropsychological Status. South Oaks Gambling Screen-Revised, NORC DSM-IV Screen for Gambling Problems.
There is no direct benefit to subjects from study participation. Future benefits to society might be better understanding of risk perception biases associated with co-occurring substance abuse and schizophrenia, leading to development of more effective prevention and treatment programs and improved processes for obtaining informed consent.
This study poses minimal risk to subjects, primarily boredom or anxiety from taking questionnaires and psychological tests and embarrassment from giving an observed urine specimen for drug testing.
|Study Design||Time Perspective: Other|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Study Completion Date||May 3, 2012|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 64 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||999909447
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute on Drug Abuse (NIDA)|
|Collaborators||University of Maryland|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 3, 2012|