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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.
Register: ClinicalTrials.gov
Last refreshed on: 7 January 2013
Main ID:  NCT01443949
Date of registration: 29/09/2011
Primary sponsor: National Institute on Drug Abuse (NIDA)
Public title: Teenagers, Drug Addiction, and Reward and Impulse Control
Scientific title: Individual Differences in Reward and Impulse Control Circuitry as Risk Factors for Addiction
Date of first enrolment: September 2011
Target sample size: 120
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01443949
Study type:  Observational
Study design:  Time Perspective: Retrospective  
Countries of recruitment
United States
Contacts
Name:   Elliot Stein, Ph.D.
Address: 
Telephone: 443-740-2650
Email: estein@mail.nih.gov
Affiliation: 
Name:   Elliot Stein, Ph.D.
Address: 
Telephone: (443) 740-2650
Email: estein@mail.nih.gov
Affiliation: 
Name:   Elliot Stein, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  National Institute on Drug Abuse (NIDA)
Key inclusion & exclusion criteria

- 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
Health Condition(s) or Problem(s) studied
Adolescents
Conduct Disorder
Vulnerability to Substance Addicition
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
11-DA-N466
999911466
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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