Imaging and Biomarkers for Opioid Use Disorder During Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how opioid use during pregnancy affects babies' development. Researchers will use MRI scans to examine the placenta and fetal brain and study genetic factors to determine their relation to withdrawal symptoms or developmental issues in children. Pregnant women with opioid use disorder, especially those on buprenorphine or methadone treatment, are well-suited for this study. Participants will undergo MRIs, complete surveys, and provide blood samples, with follow-ups to track child development milestones.
As an unphased study, this trial offers participants the chance to contribute to groundbreaking research that could enhance future care for mothers and babies.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. In fact, it requires participants to be on buprenorphine or methadone for opioid use disorder as part of a prenatal maintenance program.
What prior data suggests that this observational study is safe for participants?
Research has shown that both buprenorphine and methadone are safe for treating opioid use disorder (OUD) in pregnant women. Studies have found that buprenorphine during pregnancy can lead to better outcomes for mothers and their babies compared to methadone. Specifically, buprenorphine may result in healthier births and a lower chance of withdrawal symptoms in newborns.
Methadone remains a recommended treatment for pregnant women with OUD, requiring careful dosage adjustments to ensure the safety of both mother and baby. Both treatments are supported by research and help manage OUD during pregnancy, aiming to support healthier pregnancies and reduce risks for newborns.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores advanced imaging and biomarkers to understand the effects of opioid use disorder during pregnancy. This innovative approach offers a fresh perspective by integrating cutting-edge imaging techniques with biomarker analysis, which could provide deeper insights than standard care options like buprenorphine or methadone treatment alone. By focusing on fetal and placental health, the study aims to improve clinical outcomes, potentially leading to better care strategies for pregnant mothers with opioid use disorder and their babies.
What evidence suggests that this study's methods are effective for understanding the long-term effects of prenatal opioid exposure?
This trial will compare pregnant mothers with opioid use disorder who receive buprenorphine or methadone treatment to those without a history of opioid use disorder. Studies have shown that both buprenorphine and methadone effectively treat opioid use disorder (OUD) during pregnancy. Buprenorphine is linked to better outcomes for mothers and babies, including a lower risk of neonatal abstinence syndrome (NAS) in newborns. Methadone also proves effective and can help reduce risks associated with untreated OUD. Research indicates that treating OUD with these medications during pregnancy can lead to healthier pregnancies and improved infant health. Both treatments are well-regarded and commonly used to manage OUD in pregnant women.12467
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prenatal Assessment
Participants receive two placental-fetal MRIs, one during the second trimester and one in the third trimester, and have blood drawn during pregnancy and delivery.
Child Development Follow-up
Participants answer surveys on their child's development milestones and undergo a development assessment at one year of life.
What Are the Treatments Tested in This Trial?
Interventions
- Buprenorphine or Methadone Treatment
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment
100 pregnant mother who to not have a history of opioid use disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Buprenorphine Treatment in Pregnancy and Maternal ...
Buprenorphine treatment for OUD during pregnancy was associated with improved outcomes for mothers and infants, highlighting the importance of treatment ...
Buprenorphine Treatment in Pregnancy and Maternal- ...
Buprenorphine treatment for OUD during pregnancy was associated with improved outcomes for mothers and infants, highlighting the importance of treatment ...
Opioid Use and Opioid Use Disorder in Pregnancy
In later years, pharmacotherapy with either methadone or buprenorphine has been used for treatment of opioid use disorder 30 38 in pregnant women. The rationale ...
Review Buprenorphine-naloxone versus ...
Buprenorphine-naloxone was associated with a lower risk of neonatal abstinence syndrome and small for gestational age infants.
Buprenorphine versus Methadone for Opioid Use Disorder ...
Buprenorphine may be associated with more favorable neonatal and maternal outcomes than methadone, but existing data are limited.
Use of buprenorphine during pregnancy better for infants ...
Prior research suggested that buprenorphine may lead to better medical outcomes for infants of mothers with opioid use disorder than methadone.
RCT Comparing Methadone and Buprenorphine in ...
Past research has shown that use of buprenorphine in pregnant women results in improved birth outcomes over methadone.
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