Cocaine DependenceNCT01031563
Risk Perception in Drug-Dependent Adults With and Without Schizophrenia
An observational study of Cocaine Dependence and Cannabis Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cocaine Dependence, Cannabis Dependence, Schizophrenia
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2009to 3 May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Exclusions: schizophrenia or schizoaffective disorder; mood disorder; OCD.
- Group 3: Schizophrenia or schizoaffective disorder without drug dependence
- Inclusion: DSM-IV schizophrenia or schizoaffective disorder.
- Exclusions: mood disorder; OCD; use of illegal drugs more than 3 times in the previous month.
- Group 4: Healthy comparison participants
- Exclusions: Any DSM-IV Axis I diagnosis (except simple phobia); use of illegal drugs more than 3 times in the previous month.
- Exclusions for all groups: History of neurological disease/condition (unrelated to schizophrenia or drug dependence) with ongoing cognitive sequelae; physical limitations (e.g., with hearing, vision or movement) that would prevent performance of computerized tasks; documented mental retardation.
- Substances of choice among drug-dependent participants (Groups 1 and 2) must be marijuana, cocaine or both (the commonest illegal drugs of abuse among patients with schizophrenia).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) 55 Wade Avenue
Catonsville, Maryland, 21228
About this study
Background:
- 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.
- Previous research has indicated that individuals with schizophrenia have less of a sense of unrealistic optimism about adverse events than individuals without schizophrenia. However, research on risk perception in schizophrenia is sparse, primarily reporting on behaviors and decisions in the laboratory that likely are influenced by risk perception.
- Risk perception among substance users may be viewed in two separate categories: perception of vulnerability to adverse events and perception of vulnerability to negative outcomes associated with substance use. Research in both areas has yielded mixed results. Researchers are interested in studying the connections among schizophrenia, addiction, and risk perception in order to develop better drug use prevention and treatment programs for people with and without schizophrenia.
Read more
Objectives:
- To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Eligibility:
- Individuals between 18 and 64 years of age who fall into one of the following study categories:
- diagnoses of both drug dependence (marijuana or cocaine) and schizophrenia/schizoaffective disorder
- diagnosis of drug dependence only (marijuana or cocaine)
- diagnosis of schizophrenia/schizoaffective disorder only
- healthy volunteers with no history of drug use or serious mental disorder
Design:
- The study will require a single visit to the research center for a 5- to 6-hour session.
- Participants will complete questionnaires on medical and behavioral history, complete tests of thinking skills like memory and attention, complete a brief computerized decision-making task, and answer questions about risk perception.
- Participants will also provide urine samples and breath carbon monoxide measurements to test for recent use of tobacco and other substances.
Read the detailed description
Background:
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.
Objective:
To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Study Population:
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).
Study Design:
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.
Outcome Measures:
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.
Benefit:
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.
Risks:
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.
- Conditions
- Cocaine Dependence, Cannabis Dependence, Schizophrenia
- Keywords
- Risk Taking, Schizophrenia, Drug Abuse/Dependence, Comorbidity, Impulsivity, Drug Abuse
- Medical subject headings
- Cocaine-Related Disorders, Marijuana Abuse, Schizophrenia, Risk-Taking, Substance-Related Disorders, Impulsive Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study start18 Aug 2009
- Study completion3 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Maryland
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031563
- Sponsor's protocol ID
- 999909447
- Other IDs
- 09-DA-N447
- Status last verified
- 3 May 2012
- First submitted
- 11 Dec 2009
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Marsch LA, Bickel WK, Badger GJ, Quesnel KJ. The anatomy of risk: a quantitative investigation into injection drug users' taxonomy of risk attitudes and perceptions. Exp Clin Psychopharmacol. 2007 Apr;15(2):195-203. doi: 10.1037/1064-1297.15.2.195.
PubMed 17469943Prentice KJ, Gold JM, Carpenter WT Jr. Optimistic bias in the perception of personal risk: patterns in schizophrenia. Am J Psychiatry. 2005 Mar;162(3):507-12. doi: 10.1176/appi.ajp.162.3.507.
PubMed 15741467Cherpitel CJ. Alcohol, injury, and risk-taking behavior: data from a national sample. Alcohol Clin Exp Res. 1993 Aug;17(4):762-6. doi: 10.1111/j.1530-0277.1993.tb00837.x.
PubMed 8214410
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Perception in Drug-Dependent Adults With and Without Schizophrenia
- ClinicalTrials.gov ID
- NCT01031563
- Acronym / sponsor ID
- 999909447
- Conditions
- Cocaine Dependence, Cannabis Dependence, Schizophrenia
- Keywords
- Risk Taking, Schizophrenia, Drug Abuse/Dependence, Comorbidity, Impulsivity, Drug Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Maryland
- Study start
- 18 Aug 2009
- Study completion
- 3 May 2012
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- 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.
- Previous research has indicated that individuals with schizophrenia have less of a sense of unrealistic optimism about adverse events than individuals without schizophrenia. However, research on risk perception in schizophrenia is sparse, primarily reporting on behaviors and decisions in the laboratory that likely are influenced by risk perception.
- Risk perception among substance users may be viewed in two separate categories: perception of vulnerability to adverse events and perception of vulnerability to negative outcomes associated with substance use. Research in both areas has yielded mixed results. Researchers are interested in studying the connections among schizophrenia, addiction, and risk perception in order to develop better drug use prevention and treatment programs for people with and without schizophrenia.
Objectives:
- To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Eligibility:
- Individuals between 18 and 64 years of age who fall into one of the following study categories:
- diagnoses of both drug dependence (marijuana or cocaine) and schizophrenia/schizoaffective disorder
- diagnosis of drug dependence only (marijuana or cocaine)
- diagnosis of schizophrenia/schizoaffective disorder only
- healthy volunteers with no history of drug use or serious mental disorder
Design:
- The study will require a single visit to the research center for a 5- to 6-hour session.
- Participants will complete questionnaires on medical and behavioral history, complete tests of thinking skills like memory and attention, complete a brief computerized decision-making task, and answer questions about risk perception.
- Participants will also provide urine samples and breath carbon monoxide measurements to test for recent use of tobacco and other substances.
Detailed description
Background:
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.
Objective:
To compare unrealistic optimism bias in people with and without schizophrenia and/or drug dependence, and its association with actual risky behavior.
Study Population:
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).
Study Design:
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.
Outcome Measures:
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.
Benefit:
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.
Risks:
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
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Exclusions: schizophrenia or schizoaffective disorder; mood disorder; OCD.
- Inclusion: DSM-IV schizophrenia or schizoaffective disorder.
- Exclusions: mood disorder; OCD; use of illegal drugs more than 3 times in the previous month.
- Exclusions: Any DSM-IV Axis I diagnosis (except simple phobia); use of illegal drugs more than 3 times in the previous month.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 17469943Marsch LA, Bickel WK, Badger GJ, Quesnel KJ. The anatomy of risk: a quantitative investigation into injection drug users' taxonomy of risk attitudes and perceptions. Exp Clin Psychopharmacol. 2007 Apr;15(2):195-203. doi: 10.1037/1064-1297.15.2.195.
- Background: PubMed 15741467Prentice KJ, Gold JM, Carpenter WT Jr. Optimistic bias in the perception of personal risk: patterns in schizophrenia. Am J Psychiatry. 2005 Mar;162(3):507-12. doi: 10.1176/appi.ajp.162.3.507.
- Background: PubMed 8214410Cherpitel CJ. Alcohol, injury, and risk-taking behavior: data from a national sample. Alcohol Clin Exp Res. 1993 Aug;17(4):762-6. doi: 10.1111/j.1530-0277.1993.tb00837.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Stein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Dependence and Cannabis Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01031563, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.