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Maternal Brain Imaging in Opioid Use Disorder (BOOM Study)
R
Rupa Radhakrishnan, MD
Primary Investigator
Recruiting
18 years - 100 years
Female
Phase
N/A
40 participants needed
1 Location
Brief description of study
Why is this study being done?
The purpose of this research study is 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). We want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.
Who can take part?
We are looking for pregnant women who either have OR don't have an Opioid Use Disorder (OUD)
Additional information
Study title: Maternal Brain Imaging in Opioid Use Disorder (BOOM Study)
The study is being conducted by Dr. Rupa Radhakrishnan, MS, MD, with the Indianaversity School of Medicine, Department of Radiology at Riley Hospital for Children.
To learn more about Rupa Radhakrishnan and her research interests, please visit this link: https://medicine.iu.edu/faculty/38670/radhakrishnan-rupa
Detailed description of study
What will happen during the study?
Women with Opioid Use Disorder (OUD) will be asked to do the following:
- Medical History: We will collect some information about you, your baby, your general family medical history, mental health history, and addiction history. Some of this information may be collected from you, your family, or your medical records.
- Drug screen: you will be asked to provide a urine sample for a drug screen at the time of enrollment if there is not a recent one available in your medical chart.
- Surveys: The study staff will ask you to complete several surveys that will take around 1-1.5 hours to complete. These questionnaires will assess information about your maternal care, social support, medical history, mental health, and social support. These can be completed online, over the phone, or in person.
- Brain imaging: You will participate in a one-time MRI (magnetic resonance imaging) of the brain between 24-32 weeks of your pregnancy. An MRI scan is a test that creates clear images of your body using a large magnet. This MRI will take around 30 minutes and takes place at Riley Children’s Hospital.
- Interview: Study staff will meet with you to ask you questions about your health and social history. This may take up to 30-45 minutes to complete and can be done prior to MRI or at your convenience.
- Labs: During the brain MRI three blood samples will be drawn to assess how your body is breaking down your medications and to test for current substance use. These labs will be drawn one hour prior to MRI, immediately before MRI, and post – MRI. No more than 29mL of blood will be drawn during the entire visit.
- Medication log: You will be asked to keep a log 48 hours prior to MRI to record medication times and doses, if you are in the OUD cohort
- 3 Months Postpartum: We will collect the following information up until 3 months after you give birth: demographics, socioeconomic data, pregnancy complications, labor and delivery.
Women without OUD (Control Group)
- Medical History: We will collect some information about you, your baby, your general family medical history, mental health history, and addiction history. Some of this information may be collected from you, your family, or your medical records.
- Drug screen: you will be asked to provide a urine sample for a drug screen at the time of enrollment if there is not a recent one available in your medical chart.
- Surveys: The study staff will ask you to complete several surveys that will take around 1-1.5 hours to complete. These questionnaires will assess information about your maternal care, social support, medical history, mental health, and social support. These can be completed online, over the phone, or in person.
Brain imaging: You will participate in a one-time MRI (magnetic resonance imaging) of the brain between 24-32 weeks of your pregnancy. An MRI scan that creates clear images of your body using a large magnet. This MRI will take around 30 minutes and takes place at Riley Children’s Hospital in Indianapolis, IN. - 3 Months Postpartum: We will collect the following information up until 3 months after you give birth: demographics, socioeconomic data, pregnancy complications, labor and delivery.
Incentive/compensation
- The OUD group will receive $150 on a VISA card and the Control group will receive $125 on a VISA card for completing all of the study requirements.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Opioid Use Disorder, OUD, Pregnancy
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
Pregnant women with OUD
• Age: >18 years old
• Any subject that is currently on Buprenorphine at time of screening
• Singleton pregnancy
Control Group:
• Age: >18 years old
• Singleton pregnancy
Exclusion Criteria
Pregnant women with OUD:
• Serious maternal medical illness
• HIV or AIDs
• Score >9 on the PHQ-9, and score a >0 on item 9 which is about suicidality
• Score of 8 or more on GAD-7
• Any contraindications for MRI
• Known or suspected major fetal congenital abnormalities
Control pregnant women:
• Serious maternal medical illness
• HIV or AIDS
• Score of >9 on the PHQ-9, and a score of >0 on item 9 which is about suicidality
• Score of 8 or more on GAD-7</p>
• Known or suspected major fetal congenital abnormalities
• Any contraindications for MRI
• Opioid or polysubstance abuse as identified on urine screening
Updated on
07 Jan 2025.
Study ID: RADY-IIR-19466, 19466
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