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

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Substance Abuse Problem; Pregnancy

Treatments: Drug: Syntocinon treatment; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02872467

14-3053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

Syntocinon treatment

Experimental group

Description:

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).

Treatment:

Drug: Syntocinon treatment

Placebo

Placebo Comparator group

Description:

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Treatment:

Other: Placebo