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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01443949 |
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Date of registration:
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29/09/2011 |
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Primary sponsor: |
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Public title:
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Teenagers, Drug Addiction, and Reward and Impulse Control
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Scientific title:
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Individual Differences in Reward and Impulse Control Circuitry as Risk Factors for Addiction |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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120 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01443949 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Elliot Stein, Ph.D. |
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Address:
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Telephone:
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443-740-2650 |
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Email:
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estein@mail.nih.gov |
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Affiliation:
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Name:
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Elliot Stein, Ph.D. |
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Address:
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Telephone:
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(443) 740-2650 |
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Email:
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estein@mail.nih.gov |
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Affiliation:
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Name:
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Elliot Stein, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute on Drug Abuse (NIDA) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
All participants:
1. Between 13 and 17 years old (inclusive);
2. Must be able to provide informed assent and have a parent/guardian who can provide informed consent;
3. Blood pressure (BP) and heart rate (HR) while sitting at or below the following values after five min rest: Systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg, heart rate (HR) 100 bpm;
4. 12-lead standard ECG and three-minute rhythm strip without clinically relevant abnormalities;
5. Estimated IQ >= 85 determined by the Wechsler Abbreviated Scale of Intelligence (The Psychological Corporation, 1999);
6. Right-handed (based on Edinburgh Handedness Inventory).
7. Eligible to enter the MRI scanner, as determined though self and parent (guardian) report on the MRI screening form (from the screening protocol 06-DA-N415).
Group EE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
Group CD-NE:
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician).
Group CD-EE:
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician);
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
EXCLUSION CRITERIA
All participants:
1. Report of a history of significant medical/neurological illness that might interfere with imaging data such as HIV positive status, cerebral vascular accident (CVA), central nervous system (CNS) tumor, traumatic brain injury, multiple sclerosis (MS) or other demyelinating diseases, epilepsy, or movement disorders;
2. History of psychosis or any current DSM-IV axis I disorder (other than simple phobia and conduct disorder);
3. Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Venlafaxine, stimulants);
4. Current use of substances (not including over-the-counter medications and energy drinks) as assessed by self-report, carbon monoxide (CO) monitoring, alcohol breathalyzer and urine testing;
5. Pregnancy, which will be assessed by history during screening and by urine testing on scan days;
6. Claustrophobia by self and/or parent (guardian) report, or through response to the mock-scanner environment, severe enough to preclude toleration of the scanning environment.
Group NE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire;
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician).
Group EE:
- History of diagnosis with conduct disorder, assessed from parental report (and verified by study-clinician).
Group CD-NE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
Age minimum:
13 Years
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adolescents
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Conduct Disorder
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Vulnerability to Substance Addicition
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Secondary ID(s)
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11-DA-N466
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999911466
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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