Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally (NCT01365988) | Clinical Trial Compass
CompletedNot Applicable
Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
United States43 participantsStarted 2011-05-15
Plain-language summary
Objective- To use fMRI to compare brain activity at rest and during memory and decision making tasks in normal children and in children exposed in utero to drugs of abuse.
Study population- All participants will be 14-20 year-olds enrolled in an ongoing longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A subgroup of this study cohort will be invited to participate based on added criteria needed for scanning studies, such as absence of metal in the body, no significant CNS disease, and ability to tolerate the scanning environment.
Design- Participants will undergo fMRI scans while performing a memory task, a decision making task and at rest. Data from participants in the current study may be combined with those from a previous study (NIDA protocol 417) which now reside in our repository protocol, 8002 and NIDA protocol 455.
Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation between drug-exposed participants and those without prenatal exposure to drugs of abuse.
Who can participate
Age range14 Years – 20 Years
SexALL
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Inclusion criteria
✓. Participants must be enrolled in the current UMB longitudinal study protocol.
✓. All participants will be between 14 and 20 years old (inclusive).
✓. All participants must be able to provide informed assent and have a parent/guardian who can provide informed consent or if 18 or older, be able to provide informed consent..
Exclusion criteria
✕. 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, head trauma, multiple sclerosis (MS) or other demyelinating diseases, epilepsy, or movement disorders.
✕. Metallic devices in the body that preclude MRI scanning, as determined by self and parent (guardian) report.
✕. Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Effexor, stimulants).
✕. Currently using respiratory, cardiovascular, anticonvulsant or other medications that might interfere with the mechanisms producing the BOLD signal.
What they're measuring
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The primary outcome measures will be the difference in BOLD fMRI activation between drug-exposed participants and those without prenatal exposure to drugs of abuse.