Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development

June 30, 2017 updated by: National Institute on Drug Abuse (NIDA)

Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development: Supplementary Control Subjects Recruitment

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.

Study Overview

Status

Completed

Detailed Description

Objective- To use fMRI to compare brain activity at rest and during working memory and decision making tasks in normal children and in children exposed in utero to drugs of abuse.

Study population- All participants will be 12-17 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 working memory task, a decision making task and at rest. Data from participants in the current study will be combined with those from a previous study (NIDA protocol 417) which now reside in our repository protocol, 8002.

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.

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Catonsville, Maryland, United States, 21228
        • University of Maryland at Baltimore/MPRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:

    1. Participants must be enrolled in the current UMB longitudinal study protocol.
    2. All participants will be between 12 and 17 years old (inclusive).
    3. All participants must be able to provide informed assent and have a parent/guardian who can provide informed consent.

EXCLUSION CRITERIA:

  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, head trauma, multiple sclerosis (MS) or other demyelinating diseases, epilepsy, or movement disorders.
  2. Metallic devices in the body that preclude MRI scanning, as determined by self and parent (guardian) report.
  3. Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Effexor, stimulants).
  4. Currently using respiratory, cardiovascular, anticonvulsant or other medications that might interfere with the mechanisms producing the BOLD signal.
  5. Currently abusing street drugs as assessed by history and urine testing.
  6. Pregnancy, which will be assessed by history during screening and by urine testing on scan days.
  7. Claustrophobia by self and/or parent (guardian) report severe enough to preclude toleration of the scanning environment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 16, 2009

Study Completion

July 13, 2011

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

July 13, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 999910455
  • 10-DA-N455

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Abuse

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