Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT01134770

Prenatal Exposure Effects Psychophysiology Study

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

The investigators are looking for pregnant women or mothers with their newborn infants to participate in this study. Eligible women include mothers who have used any of the following drugs at any time during pregnancy (alone or in combination):

  • cocaine
  • nicotine (cigarettes)
  • marijuana
  • alcohol

The investigators are also looking for mothers who have not used any drugs during pregnancy.

Information collected in this research study is strictly confidential, and protection of sensitive information is additionally assured by an NIH Certificate of Confidentiality.

Participation in this study involves:

  • One visit at 2-4 weeks postpartum. This visit includes an interview for mother and a 30 minute brain scan (no radiation, no sedation) for baby.
  • Two visits at 3 months postpartum. Mothers will have blood pressure and heart rate measured while they look at videos about babies, listen to baby sounds, interact with their own baby. Samples of blood, urine and saliva will be taken from mother. Baby will have a developmental assessment, and saliva samples will be taken.

Payment is $300 or the equivalent in Walmart gift cards for completion of brain imaging, lab visits and 1 day of monitoring mother's blood pressure at home.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • During pregnancy, mother has used any of the following:
  • cocaine
  • marijuana and/or alcohol but not cocaine
  • nicotine (smoked cigarettes)
  • no drugs during pregnancy
  • Mother is pregnant or no more than 4 weeks postpartum

Exclusion criteria

  • Mother has cardiovascular disease
  • Delivery before 36 weeks or later than 42 weeks gestation
  • Birth weight less than 5.5 lbs
  • Baby was a multiple birth

Treatment and study plan

Primary outcomes

  1. Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes

    Time frame: 2 to 4 weeks of age

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

Acronym: PEEPS

Important dates

Study start
2008
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2010
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.