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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD096800-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | Planned recruitment of 200 pregnant (<16weeks) mothers who have opioid use disorder and are taking buprenorphine |
| |
| Pregnant Mothers | Planned recruitment of 100 pregnant (>16weeks) mothers who do not have any history of opioid use disorder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subutex / Buprenorphine | Drug | Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of opioid misuse severity using assessments | Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D. | 5 years |
| Pharmacological treatment for neonatal abstinence syndrome | Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse effects of buprenorphine using MRI | Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI. | 5 years |
| Concentration of long-term neurodevelopmental outcomes using assessments |
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Inclusion Criteria:
Exclusion Criteria:
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Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Senthil Sadhasivam, MD, MPH | Contact | 4126474484 | sadhasivams@upmc.edu | |
| Carly Riedmann, MPH | Contact | 4126234147 | riedmannca@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Senthil Sadhasivam, MD, MPH | University of Pittsburgh, UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Children's Hospital | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Collection of DNA/Genetic/Epigenetic Samples from the mother at enrollment, then the infant at birth.
| Fetal & Neonatal MRI | Diagnostic Test | Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI. |
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| DNA/Genetic/Pharmacokenetic Blood Draws | Diagnostic Test | Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples. |
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Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
| 5 years |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |