Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R03DA056797-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening. |
| |
| Pregnant Mothers | Planned recruitment of 20 mothers who do not have any history of opioid use disorder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | Pregnant mother must be taking Buprenorphine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI. | During MRI visit between 24-32 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD | During MRI visit between 24-32 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Assess differences in brain gray matter volumes in pregnant women with OUD compared to pregnant women without OUD. | During MRI visit between 24-32 weeks gestational age | |
| Assess differences in brain white matter microstructure on Diffusion Tensor Imaging (DTI) in pregnant women with OUD compared to pregnant women without OUD. |
Pregnant Women with OUD
Inclusion Criteria:
Exclusion Criteria:
Pregnant Women with no history of OUD
Inclusion:
Exclusion:
Not provided
Not provided
Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Biosamples:
During the MRI visit blood samples will be collected to estimate steady-state plasma level of buprenorphine using a population pharmacokinetic approach.
| Maternal Brain MRI | Diagnostic Test | Maternal Brain MRI obtained between 24-32 week gestation |
|
| Blood Samples | Other | During the MRI visit blood samples will be drawn: one hour prior to MRI, immediately before MRI, and one hour post MRI to test for Buprenorphine levels. |
|
| Questionnaires | Behavioral | Participants will answer questionnaires about their medical history, pregnancy, and substance use. |
|
| During MRI visit between 24-32 weeks gestational age |
| Correlate alterations in brain gray matter volume and DTI metrics with steady state plasma buprenorphine exposure in pregnant women with OUD | During MRI visit between 24-32 weeks gestational age |
| 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 |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |