Risk Perception in Drug-Dependent Adults With and Without Schizophrenia
|First Received Date ICMJE||December 11, 2009|
|Last Updated Date||May 4, 2012|
|Start Date ICMJE||August 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01031563 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Risk Perception in Drug-Dependent Adults With and Without Schizophrenia|
|Official Title ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||120|
|Completion Date||May 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 64 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01031563|
|Other Study ID Numbers ICMJE||999909447, 09-DA-N447|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||University of Maryland|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP