Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology (NOX)
Primary Purpose
Substance Abuse Problem, Pregnancy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Syntocinon treatment
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Substance Abuse Problem focused on measuring Cocaine, Mothers, Pregnant women, Postpartum women, Oxytocin, Substance use disorders, Substance abuse, Prenatal substance use, stress
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)
Sites / Locations
- UNC School of Medicine, Medical School Wing D
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Syntocinon treatment
Placebo
Arm 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).
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Outcomes
Primary Outcome Measures
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
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.
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.
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.
Full Information
NCT ID
NCT02872467
First Posted
July 12, 2016
Last Updated
April 14, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02872467
Brief Title
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Acronym
NOX
Official Title
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2023 (Actual)
Study Completion Date
March 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse Problem, Pregnancy
Keywords
Cocaine, Mothers, Pregnant women, Postpartum women, Oxytocin, Substance use disorders, Substance abuse, Prenatal substance use, stress
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Syntocinon treatment
Arm Type
Experimental
Arm 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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Intervention Type
Drug
Intervention Name(s)
Syntocinon treatment
Other Intervention Name(s)
Nasal Oxytocin treatment
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
Primary Outcome Measure Information:
Title
The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 weeks
Title
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.
Time Frame
2 weeks
Title
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.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Grewen, Ph.D.
Organizational Affiliation
UNC School of Medicine, Dept. of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC School of Medicine, Medical School Wing D
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7175
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology
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