Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Foundation of Hope, North Carolina
• Treatments: Cocaine; Oxytocin

Criteria

Inclusion Criteria:

• 3-6 months postpartum at start of testing

• Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology)

• Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk)

• Healthy singleton pregnancy

• English fluency that will allow informed consent

Exclusion Criteria:

• Pregnancy or plans to become pregnant during participation in the study

• Not using effective birth control methods to prevent pregnancy

• Breastfeeding for any infant milk feedings

• Mother is not currently living with the infant during the trial period

• Multiple birth (twin, triplet or greater)