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

Neural Correlates of Risk-Taking in Urban Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01365988
Enrollment
43
Registered
2011-06-03
Start date
2011-05-15
Completion date
2013-02-26
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exposure

Keywords

fMRI, Risk-Taking, Decision-Making, Memory, Resting-State Functional Connectivity

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.

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.

Interventions

None listed

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
14 Years to 20 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026