Prenatal Exposure Effects Psychophysiology Study

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT01134770
Status
Enrolling By Invitation

Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Study Details

The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures. The investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette smoking affect both mother and baby.

Key Dates

Start date
Jul 31, 2008
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Prenatal Cocaine
    Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
  • Arm: Prenatal Nicotine-Alcohol-Marijuana
    Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.
  • Arm: Drug-Free Pregnancy
    Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana.

Primary Outcome Measure

Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes [ Time Frame: 2 to 4 weeks of age ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

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