Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02872467
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOX
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: