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

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ClinicalTrials.gov Identifier: NCT02872467
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Foundation of Hope, North Carolina
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872467


Contacts
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Contact: Pamela Beiler, MSW 919-843-3419 beiler@email.unc.edu

Locations
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United States, North Carolina
UNC School of Medicine, Medical School Wing D Recruiting
Chapel Hill, North Carolina, United States, 27599-7175
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina
Investigators
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Principal Investigator: Karen Grewen, Ph.D. UNC School of Medicine, Dept. of Psychiatry

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02872467     History of Changes
Other Study ID Numbers: 14-3053
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Cocaine
Mothers
Pregnant women
Postpartum women
Oxytocin
Substance use disorders
Substance abuse
Prenatal substance use
stress

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxytocin
Cocaine
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents