CompletedPhase 1

Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

United States31 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range18 Years – 42 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity

Timeframe: 2 weeks

Trial details

NCT IDNCT02872467

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03

View on ClinicalTrials.gov More Substance Abuse Problem trials