Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology (NOX)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Substance Abuse Problem
• Intervention / Treatment: Drug: Syntocinon treatment; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7175
      • UNC School of Medicine, Medical School Wing D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Syntocinon treatment; Syntocinon spray, 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).	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 Names: Nasal Oxytocin treatment
Placebo Comparator: Placebo; Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.	Other: Placebo; Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Foundation of Hope, North Carolina
• Investigators: Principal Investigator: Karen Grewen, Ph.D., UNC School of Medicine, Dept. of Psychiatry

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Oxytocin; stress; Cocaine; Postpartum women; Substance use disorders; Pregnant women; Substance abuse; Mothers; Prenatal substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 14-3053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO