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Prenatal Drug Exposure clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT01020669 Completed - Drug Abuse Clinical Trials

Prenatal Drug Exposure: Effects on the Adolescent Brain and Behavior Development

Start date: October 16, 2009
Phase: N/A
Study type: Observational

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.