Neutral Correlates of Risk-taking in Adolescents Exposed... | NCT01365988

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

NCT01365988

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Exposure

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
11-DA-N468

Status Module

Record Verification Date

Feb 26, 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2011

Primary Completion Date

Not provided

Completion Date

Feb 26, 2013

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 3, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time 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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Betty Jo Salmeron, M.D.	National Institute on Drug Abuse (NIDA)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland at Baltimore/MPRC		Catonsville	Maryland	21228	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11909933	Background	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.
11792524	Background	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.