Maternal Brain Imaging in Opioid Use Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Maternal Brain Imaging in Opioid Use Disorder

Conditions
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Substance Use, Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence

Intervention / Treatment
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* Drug: Buprenorphine
* Diagnostic Test: Maternal Brain MRI
* Other: Blood Samples
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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Pregnant Women with OUD Inclusion Criteria: Age: >18 years old Any subject that is currently on Buprenorphine at time of screening Singleton pregnancy Exclusion Criteria: Serious maternal medical illness HIV or AIDs Polysubstance use Score >9 on the PHQ-9, and score >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 Pregnant Women with no history of OUD Inclusion: Age: >18 years old Singleton pregnancy Exclusion: 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 Known or suspected major fetal congenital abnormalities Any contraindications for MRI Opioid or polysubstance abuse as identified on urine screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant Mothers with Opioid Use Disorder<br>Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening. | Drug: Buprenorphine<br>* Pregnant mother must be taking Buprenorphine<br>Diagnostic Test: Maternal Brain MRI<br>* Maternal Brain MRI obtained between 24-32 week gestation<br>Other: Blood Samples<br>* 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.<br>Behavioral: Questionnaires<br>* Participants will answer questionnaires about their medical history, pregnancy, and substance use.<br>|
| Pregnant Mothers<br>Planned recruitment of 20 mothers who do not have any history of opioid use disorder. | Diagnostic Test: Maternal Brain MRI<br>* Maternal Brain MRI obtained between 24-32 week gestation<br>Behavioral: Questionnaires<br>* Participants will answer questionnaires about their medical history, pregnancy, and substance use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid Use Disorder, Pregnant with Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex