ExposureNCT01365988
Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
An observational study of Exposure, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2011to 26 Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must be enrolled in the current UMB longitudinal study protocol.
- All participants will be between 14 and 20 years old (inclusive).
- 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..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland at Baltimore/MPRC
Catonsville, Maryland, 21228
About this study
Official title: Neural Correlates of Risk-Taking in Urban Adolescents
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.
Read more
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.
Read the 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.
- Conditions
- Exposure
- Keywords
- fMRI, Risk-Taking, Decision-Making, Memory, Resting-State Functional Connectivity
- Medical subject headings
- Risk-Taking
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study start15 May 2011
- Study completion26 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Betty Jo Salmeron, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365988
- Sponsor's protocol ID
- 999911468
- Other IDs
- 11-DA-N468
- Status last verified
- 26 Feb 2013
- First submitted
- 1 Jun 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
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.
PubMed 11909933Bandstra 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.
PubMed 11792524Bandstra ES, Vogel AL, Morrow CE, Xue L, Anthony JC. Severity of prenatal cocaine exposure and child language functioning through age seven years: a longitudinal latent growth curve analysis. Subst Use Misuse. 2004 Jan;39(1):25-59. doi: 10.1081/ja-120027765.
PubMed 15002943
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Risk-Taking in Urban Adolescents
- ClinicalTrials.gov ID
- NCT01365988
- Acronym / sponsor ID
- 999911468
- Conditions
- Exposure
- Keywords
- fMRI, Risk-Taking, Decision-Making, Memory, Resting-State Functional Connectivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 15 May 2011
- Study completion
- 26 Feb 2013
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 11909933Accornero 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.
- Background: PubMed 11792524Bandstra 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.
- Background: PubMed 15002943Bandstra ES, Vogel AL, Morrow CE, Xue L, Anthony JC. Severity of prenatal cocaine exposure and child language functioning through age seven years: a longitudinal latent growth curve analysis. Subst Use Misuse. 2004 Jan;39(1):25-59. doi: 10.1081/ja-120027765.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty Jo Salmeron, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exposure, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365988, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.