Neutral Correlates of Risk-taking in Adolescents Exposed to Drugs Prenatally
NCT ID: NCT01365988
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2011-05-15
2013-02-26
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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OTHER
Eligibility Criteria
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Inclusion Criteria
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
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.
14 Years
20 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Principal Investigators
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Betty Jo Salmeron, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute on Drug Abuse (NIDA)
Locations
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University of Maryland at Baltimore/MPRC
Catonsville, Maryland, United States
Countries
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References
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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.
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.
Bandstra 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.
Other Identifiers
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11-DA-N468
Identifier Type: -
Identifier Source: secondary_id
999911468
Identifier Type: -
Identifier Source: org_study_id
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