Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prenatal Cocaine, Nasal Oxytocin, and Maternal Psychophysiology

Conditions
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Substance Abuse Problem, Pregnancy

Intervention / Treatment
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* Drug: Syntocinon treatment
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syntocinon treatment<br>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<br>* 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).<br>* Other names: Nasal Oxytocin treatment;|
| Placebo Comparator: Placebo<br>Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. | Other: Placebo<br>* Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Mothers, Pregnant women, Postpartum women, Oxytocin, Substance use disorders, Substance abuse, Prenatal substance use, stress