Clinical trial NCT02872467: Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Official title: Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Abuse Problem
Pregnancy
Keywords: Cocaine
Mothers
Pregnant women
Postpartum women
Oxytocin
Substance use disorders
Substance abuse
Prenatal substance use
stress
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation of Hope, North Carolina
First posted: 2016-08-19
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
timeFrame: 2 weeks
Secondary outcomes:
measure: 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.
timeFrame: 2 weeks
measure: 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.
timeFrame: 2 weeks
measure: 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.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Medicine, Medical School Wing D
state: North Carolina
Study officials:
affiliation: UNC School of Medicine, Dept. of Psychiatry
name: Karen Grewen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: