Clinical Trials Directory

Trials / Completed

CompletedNCT03606473

Brain Mechanisms in Young Adults

Exploration of Mechanisms of Effects of Prenatal Cocaine Exposure in Young Adults

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Gale Richardson · Academic / Other
Sex
All
Age
25 Years – 30 Years
Healthy volunteers
Not accepted

Summary

The goal of this study is to use \[C-11\]NPA and amphetamine (oral, 0.5 mg/kg) to measure striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison subjects (COMP)

Detailed description

Prenatal cocaine exposure (PCE) has consistently been associated with behavioral deficits through childhood, adolescence, and young adulthood in our ongoing study (PRO15080516 - Effects of Prenatal Cocaine Use: 25-Year Follow-Up). Further, 21-year-olds with PCE in our study were twice as likely to have been arrested as non-exposed offspring, were more likely to be diagnosed with Conduct Disorder, had higher disinhibition scores, were significantly more likely to use alcohol and marijuana earlier, and to have earlier sexual intercourse. The effects of PCE on the developing nervous system may cause changes in brain function that underlie these behavioral outcomes. This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with \[C-11\]NPA, in striatal regions of interest in subjects who have a history of exposure to prenatal cocaine (PCE). We hypothesize that PCE is associated with increases in dopamine in the striatum relative to COMP. This may explain the impulsivity and high risk behaviors in PCE subjects

Conditions

Interventions

TypeNameDescription
DRUGd-amphetamineis used to stimulate dopamine release in the brain
RADIATION[C-11]NPAPET radiotracer

Timeline

Start date
2018-01-24
Primary completion
2020-08-31
Completion
2020-08-31
First posted
2018-07-30
Last updated
2020-09-03

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03606473. Inclusion in this directory is not an endorsement.