Buprenorphine for Opioid Use Disorder During Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how opioid use disorder (OUD) affects pregnant women and their babies, focusing on the treatment medication Buprenorphine. Researchers aim to understand how the body processes this medication during pregnancy and whether it impacts the brain differently compared to mothers without OUD. The trial includes two groups: pregnant women with OUD on Buprenorphine and pregnant women without a history of OUD. It suits pregnant women with OUD currently taking Buprenorphine and those without any history of opioid use.
As an unphased trial, this study provides a unique opportunity to contribute to understanding the effects of Buprenorphine during pregnancy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are already on Buprenorphine, you can continue taking it as part of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that buprenorphine is a safe and effective treatment for opioid use disorder (OUD) during pregnancy. Studies have found that buprenorphine leads to better health outcomes for both mothers and their babies compared to treatments like methadone. For instance, babies born to mothers taking buprenorphine often experience fewer issues, such as withdrawal symptoms after birth, known as neonatal abstinence syndrome.
Pregnant women tolerate buprenorphine well, and health organizations recommend it for managing OUD during pregnancy. This evidence supports its safety and effectiveness, making it a reliable choice for those considering treatment. For those thinking about joining a trial involving buprenorphine, these findings suggest it is generally safe and beneficial.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring how opioid use disorder affects the brains of pregnant mothers using brain imaging techniques. Unlike typical treatments that focus solely on managing symptoms with medications like methadone or buprenorphine, this trial aims to understand the neurological changes in the maternal brain. By comparing pregnant mothers with and without opioid use disorder, scientists hope to uncover insights that could lead to more targeted and effective interventions in the future. This approach goes beyond symptom management to potentially inform personalized treatments and improve outcomes for both mothers and their babies.
What evidence suggests that this trial's treatments could be effective for opioid use disorder during pregnancy?
In this trial, one group of participants will include pregnant mothers with opioid use disorder who are on Buprenorphine at the time of screening. Research has shown that Buprenorphine effectively treats opioid use disorder (OUD) during pregnancy. Studies indicate that this treatment leads to better outcomes for both mothers and babies. Specifically, Buprenorphine is linked to a lower risk of withdrawal symptoms in newborns and fewer cases of babies being smaller than expected for their age. Additionally, women using Buprenorphine along with therapy have a reduced risk of losing the baby during pregnancy and going into labor too early. Overall, Buprenorphine may provide better results than other treatments like methadone, although more research is needed to confirm this.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
Treatment
Participants receive medication-assisted therapy (MAT) during pregnancy to study its breakdown and effectiveness
Brain Imaging
Participants undergo brain imaging to assess the effects of medication and OUD on brain structure and function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Buprenorphine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening.
Planned recruitment of 20 mothers who do not have any 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
Review Buprenorphine-naloxone versus ...
Buprenorphine-naloxone was associated with a lower risk of neonatal abstinence syndrome and small for gestational age infants.
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 ...
Associations between maternal opioid use disorder ...
Women receiving both medications and therapy had significantly lower odds of fetal death (OR = 0.769, 95% CI: 0.684–0.864), and preterm labor ( ...
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 ...
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.
Treatment of Opioid Use Disorder Before, During, and After ...
Methadone and buprenorphine are recommended medications for pregnant women with OUD. Talk to your healthcare provider about treatment options ...
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