Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT01020669
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
Study Overview
Official Title:
Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development: Supplementary Control Subjects Recruitment
Status:
COMPLETED
Status Verified Date:
2011-07-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
\- 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.
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 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-DA-N455 | None | None | View |