Drug AbuseNCT01020669
Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development
An observational study of Drug Abuse and Prenatal Drug Exposure, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse, Prenatal Drug Exposure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2009to 13 Jul 2011
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must be enrolled in the current UMB longitudinal study protocol.
- All participants will be between 12 and 17 years old (inclusive).
- All participants must be able to provide informed assent and have a parent/guardian who can 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.
- Currently abusing street drugs as assessed by history and urine testing.
- 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: Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development: Supplementary Control Subjects Recruitment
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.
Read more
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.
Read the 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.
- Conditions
- Drug Abuse, Prenatal Drug Exposure
- Keywords
- fMRI, Prenatal Drug Exposure, Decision Making, Working Memory, Vulnerability
- Medical subject headings
- Substance-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start16 Oct 2009
- Study completion13 Jul 2011
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 Drug AbuseStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020669
- Sponsor's protocol ID
- 999910455
- Other IDs
- 10-DA-N455
- Status last verified
- 13 Jul 2011
- First submitted
- 24 Nov 2009
- Last updated
- 2 Jul 2017
- 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 11792524Ashtari M, Kumra S, Bhaskar SL, Clarke T, Thaden E, Cervellione KL, Rhinewine J, Kane JM, Adesman A, Milanaik R, Maytal J, Diamond A, Szeszko P, Ardekani BA. Attention-deficit/hyperactivity disorder: a preliminary diffusion tensor imaging study. Biol Psychiatry. 2005 Mar 1;57(5):448-55. doi: 10.1016/j.biopsych.2004.11.047.
PubMed 15737658
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development: Supplementary Control Subjects Recruitment
- ClinicalTrials.gov ID
- NCT01020669
- Acronym / sponsor ID
- 999910455
- Conditions
- Drug Abuse, Prenatal Drug Exposure
- Keywords
- fMRI, Prenatal Drug Exposure, Decision Making, Working Memory, Vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 16 Oct 2009
- Study completion
- 13 Jul 2011
- First posted
- 25 Nov 2009 (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.
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.
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 design
- Time perspective
- Other
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
Key exclusion criteria (7 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.
- Currently abusing street drugs as assessed by history and urine testing.
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
Not reported in the source record.
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 2 Jul 2017.
- 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 15737658Ashtari M, Kumra S, Bhaskar SL, Clarke T, Thaden E, Cervellione KL, Rhinewine J, Kane JM, Adesman A, Milanaik R, Maytal J, Diamond A, Szeszko P, Ardekani BA. Attention-deficit/hyperactivity disorder: a preliminary diffusion tensor imaging study. Biol Psychiatry. 2005 Mar 1;57(5):448-55. doi: 10.1016/j.biopsych.2004.11.047.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drug Abuse and Prenatal Drug 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 7 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020669, 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 2 Jul 2017.