Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01365988
First received: June 1, 2011
Last updated: August 20, 2013
Last verified: February 2013
  Purpose

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.


Condition
Exposure

Study Type: Observational
Official Title: Neural Correlates of Risk-Taking in Urban Adolescents

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary 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.

Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: February 2013
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Participants must be enrolled in the current UMB longitudinal study protocol.
    2. All participants will be between 14 and 20 years old (inclusive).
    3. 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:

  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. Pregnancy, which will be assessed by history during screening and by urine testing on scan days.
  6. Claustrophobia by self and/or parent (guardian) report severe enough to preclude toleration of the scanning environment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365988

Locations
United States, Maryland
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
Investigators
Principal Investigator: Betty Jo Salmeron, M.D. National Institute on Drug Abuse (NIDA)