Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development
2 other identifiers
observational
24
1 country
1
Brief Summary
Background: \- Recent research has suggested that prenatal exposure to drugs may affect specific brain processes, including working memory, stress response, and decision making. However, most of the research on the effects of prenatal drug exposure in humans has been conducted early in life, and very little is known about effects of prenatal drug exposure during the crucial brain development period that takes place during puberty and adolescence. The biological and psychological changes associated with puberty may increase adolescents' sensitivity to prenatal substance exposure. Researchers are interested in using functional magnetic resonance imaging (fMRI) scans to study brain function and learn more about the effects of prenatal drug exposure on adolescents. Objectives: \- To examine the effects of prenatal substance exposure on working memory, decision making, and normal brain activity in adolescents. Eligibility: \- Adolescents between 12 and 17 years of age who are enrolled in a larger follow-up study of children exposed to drugs in utero. Design:
- The study will involve a single outpatient session with two fMRI scans that will test working memory and decision-making processes.
- Participants will have brief medical history, a physical examination, and a urine test for drugs of abuse.
- Participants will then be trained on the working memory and decision-making tasks before having an initial MRI scan to provide a baseline reading.
- The fMRI scans will take 40 to 45 minutes each, and participants will have break in between as needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2009
CompletedFirst Submitted
Initial submission to the registry
November 24, 2009
CompletedFirst Posted
Study publicly available on registry
November 25, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2011
CompletedJuly 2, 2017
July 13, 2011
November 24, 2009
June 30, 2017
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Participants must be enrolled in the current UMB longitudinal study protocol.
- All participants will be between 12 and 17 years old (inclusive).
- All participants must be able to provide informed assent and have a parent/guardian who can provide informed consent.
You may not qualify if:
- 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.
- Currently abusing street drugs as assessed by history and urine testing.
- Pregnancy, which will be assessed by history during screening and by urine testing on scan days.
- Claustrophobia by self and/or parent (guardian) report severe enough to preclude toleration of the scanning environment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, 21228, United States
Related Publications (3)
Accornero VH, Morrow CE, Bandstra ES, Johnson AL, Anthony JC. Behavioral outcome of preschoolers exposed prenatally to cocaine: role of maternal behavioral health. J Pediatr Psychol. 2002 Apr-May;27(3):259-69. doi: 10.1093/jpepsy/27.3.259.
PMID: 11909933BACKGROUNDBandstra ES, Morrow CE, Anthony JC, Accornero VH, Fried PA. Longitudinal investigation of task persistence and sustained attention in children with prenatal cocaine exposure. Neurotoxicol Teratol. 2001 Nov-Dec;23(6):545-59. doi: 10.1016/s0892-0362(01)00181-7.
PMID: 11792524BACKGROUNDAshtari M, Kumra S, Bhaskar SL, Clarke T, Thaden E, Cervellione KL, Rhinewine J, Kane JM, Adesman A, Milanaik R, Maytal J, Diamond A, Szeszko P, Ardekani BA. Attention-deficit/hyperactivity disorder: a preliminary diffusion tensor imaging study. Biol Psychiatry. 2005 Mar 1;57(5):448-55. doi: 10.1016/j.biopsych.2004.11.047.
PMID: 15737658BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- OTHER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 24, 2009
First Posted
November 25, 2009
Study Start
October 16, 2009
Study Completion
July 13, 2011
Last Updated
July 2, 2017
Record last verified: 2011-07-13