Prenatal Exposure Effects Psychophysiology Study

NCT01134770 | Enrolling By Invitation

• 1 other identifier: 08-1092
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Prenatal Substance Use; Cocaine; Cigarette Smoking; Mothers; Pregnant women; Smoking Mothers

Outcome Measures

Primary Outcomes (1)

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

  2 to 4 weeks of age

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women or mothers with their newborn infants.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma from mothers and buccal cells from infants will be stored for possible DNA analysis of target genes pending additional funding.

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Karen Grewen, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: July 1, 2008
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)