NCT01020669

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2011

Completed
Last Updated

July 2, 2017

Status Verified

July 13, 2011

First QC Date

November 24, 2009

Last Update Submit

June 30, 2017

Conditions

Keywords

fMRIPrenatal Drug ExposureDecision MakingWorking MemoryVulnerability

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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: 11909933BACKGROUND
  • Bandstra 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: 11792524BACKGROUND
  • Ashtari 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

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

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

Locations