NCT01365988

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

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

May 15, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2013

Completed
Last Updated

April 5, 2018

Status Verified

February 26, 2013

First QC Date

June 1, 2011

Last Update Submit

April 4, 2018

Conditions

Keywords

fMRIRisk-TakingDecision-MakingMemoryResting-State Functional Connectivity

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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..

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.
  • 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
  • Bandstra ES, Vogel AL, Morrow CE, Xue L, Anthony JC. Severity of prenatal cocaine exposure and child language functioning through age seven years: a longitudinal latent growth curve analysis. Subst Use Misuse. 2004 Jan;39(1):25-59. doi: 10.1081/ja-120027765.

    PMID: 15002943BACKGROUND

MeSH Terms

Conditions

Risk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Betty Jo Salmeron, M.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

May 15, 2011

Study Completion

February 26, 2013

Last Updated

April 5, 2018

Record last verified: 2013-02-26

Locations