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| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
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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.
Participation for mothers when they are 3-6 months postpartum includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Syntocinon treatment | Experimental | 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 | Placebo Comparator | Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Syntocinon treatment | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity | 2 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Grewen, Ph.D. | UNC School of Medicine, Dept. of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC School of Medicine, Medical School Wing D | Chapel Hill | North Carolina | 27599-7175 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Placebo | Other | Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin. |
|
| 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 |