NOX: Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Suspended

CT.gov ID

NCT02872467

Collaborator

Foundation of Hope, North Carolina (Other)

Enrollment

Location

Arms

81.1

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Abuse Problem Pregnancy	Drug: Syntocinon treatment Other: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity [2 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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