Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Pregnancy Clinical Trial

— NOX  

Official title:

Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872467
• Other study ID #: 14-3053
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: March 2023

Study information

• Verified date: February 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy
• Substance Abuse Problem
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	UNC School of Medicine, Medical School Wing D	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation of Hope, North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity		2 weeks
Secondary	The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.		2 weeks
Secondary	The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.		2 weeks
Secondary	The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.		2 weeks