Prenatal Exposure Effects Psychophysiology Study (PEEPS)

Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy

Detailed Description

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):

1. cocaine
2. nicotine (cigarettes)
3. marijuana
4. 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:

1. 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.
2. 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women or mothers with their newborn infants.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Prenatal Cocaine; Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
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.
Drug-Free Pregnancy; Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Karen Grewen, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 28, 2010
• First Submitted That Met QC Criteria: May 28, 2010
• First Posted (Estimated): June 2, 2010

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cocaine; Cigarette Smoking; Pregnant women; Mothers; Prenatal Substance Use; Smoking Mothers
• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Smoking; Tobacco Use; Cigarette Smoking
• Other Study ID Numbers: 08-1092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO