NCT02872467

Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participation for mothers when they are 3-6 months postpartum includes: * Visit 1: Questionnaires and interviews about participants' health, pregnancy, moods, psychological history and drug use during pregnancy and postpartum. * Visit 2: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, instruction re: using nasal spray (oxytocin or placebo) \& self-administration of first nasal spray dose, followed by 90 minutes of monitoring. * At-home nasal spray: Twice daily (before breakfast and supper) nasal spray self-administration for 14 days. * Visit 3: Pregnancy \& drug tests (results are confidential), blood samples and vital signs, video-taped mother-infant interaction, speech task, interviews and questionnaires about mothers' experience with the nasal spray, and changes in mood or physical discomfort during the 2-weeks when taking the nasal spray. * 3 telephone interviews while subjects are taking nasal spray, and 1 post-trail telephone follow-up.

Conditions

• Substance Abuse Problem
• Pregnancy

Interventions

Type	Name	Description
DRUG	Syntocinon treatment	24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).
OTHER	Placebo	Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Timeline

• Start date: 2016-05-01
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2016-08-19
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States