Treatment Model for Maternal Opioid Use Disorder and Infant Withdrawal

(SUPPORT Trial)

Recruiting at 2 trial locations

Overseen By Emma Farber, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Buprenorphine

Disqualifiers: Severe psychopathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create a treatment model for mothers with opioid use disorder (OUD) and their newborns experiencing withdrawal in the neonatal intensive care unit (NICU). Researchers seek to develop and test a method to provide OUD treatment directly in the NICU, enabling mothers to receive help while staying close to their babies. This includes implementing a model for co-located MOUD (medication for opioid use disorder) prescription, potentially involving medications like Methadone, Buprenorphine, Subutex, or Suboxone. The study will evaluate the practicality and acceptability of this new approach for both mothers and healthcare providers. Mothers with OUD who have given birth in the last four weeks and have a baby in a NICU due to withdrawal symptoms are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity for mothers to contribute to pioneering research that could transform NICU care for families affected by OUD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should have untreated opioid use disorder, which might imply that you should not be on medication-assisted treatment or buprenorphine when joining the study.

What prior data suggests that this protocol is safe for maternal OUD treatment and infant care?

Research has shown that buprenorphine, a common treatment for opioid use disorder (OUD), is generally safe for pregnant women and their babies. Studies have found that buprenorphine leads to better health outcomes for both mothers and infants compared to methadone, another treatment option for OUD.

One study found that buprenorphine can lead to healthier births and is often easier for mothers to handle than methadone. Another study showed that babies born to mothers who took buprenorphine had better health outcomes. Methadone, while also used, can cause mild withdrawal symptoms if the dosage is too low, which may stress both mother and baby.

Overall, these findings suggest that buprenorphine is a well-tolerated treatment for maternal opioid use disorder, with positive results for newborns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Implementation Model for Co-located MOUD (Medication for Opioid Use Disorder) Prescription because it aims to streamline care for mothers with opioid use disorder and their infants experiencing withdrawal. Unlike traditional methods where treatments for mothers and infants are often handled separately, this model brings everything together in one place, making it easier for families to receive comprehensive care. This integrated approach not only potentially improves health outcomes but also enhances accessibility and coordination of care, which could be a game-changer for affected families.

What evidence suggests that this protocol is effective for maternal opioid use disorder and infant withdrawal?

Research has shown that using buprenorphine to treat opioid use disorder (OUD) during pregnancy can improve health outcomes for both mothers and their babies. Studies suggest that buprenorphine may be more effective than methadone, another common treatment option. Specifically, research indicates that pregnant women using buprenorphine tend to have healthier births compared to those using methadone. The combination treatment of buprenorphine-naloxone is also considered safe for both mothers and newborns. This trial will implement a model for co-located MOUD prescription, which includes these treatments, in neonatal intensive care units (NICUs) to potentially benefit mothers and their babies dealing with OUD. ^{1 2 3 5 6}

Who Is on the Research Team?

Sara Kornfield, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for postpartum mothers with Opioid Use Disorder (OUD) who have infants experiencing Neonatal Abstinence Syndrome (NAS) in the NICU. The study aims to help these mothers by providing treatment at their baby's bedside.

Inclusion Criteria

Mothers in Aim 1 should be diagnosed with opioid use disorder

Interview Participants in Aim 1 should be proficient in English language

Clinicians in Aim 3 should meet the inclusion criteria for interview participants

Exclusion Criteria

I do not have thoughts of harming myself or severe mental health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Needs Assessment

Conduct in-depth qualitative interviews with NICU mothers and clinicians to assess needs and identify barriers and facilitators for OUD treatment.

Up to 9 months

Multiple interviews (in-person or virtual)

Protocol Development

Develop a protocol for implementing maternal OUD treatment at the NICU bedside with the advisory board.

Up to 9 months

Pilot Implementation

Implement and evaluate the adapted intervention in two partner NICUs to determine feasibility and acceptability.

Up to 1 year

Ongoing participation during NICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including retention in outpatient treatment.

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Implementation Model for Co-located MOUD Prescription

Trial Overview The trial is testing a new model where Medications for Opioid Use Disorder (MOUD) are prescribed right in the NICU. It involves assessing needs, creating protocols with experts, and evaluating how well this approach works in two NICUs.

How Is the Trial Designed?

Group I: Case Series Experimental Treatment 1 Intervention

In Aim 3, all recruited participants will receive the intervention.

Implementation Model for Co-located MOUD Prescription is already approved in United States, European Union for the following indications:

Approved in United States as Methadone for:

• Opioid use disorder in pregnant women

Approved in United States as Buprenorphine for:

• Opioid use disorder in pregnant women

Approved in European Union as Methadone for:

• Opioid dependence

Approved in European Union as Buprenorphine for:

• Opioid dependence

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a study of 588 mother-neonate pairs, neonates born to mothers treated with buprenorphine/naloxone had a significantly lower prevalence of neonatal opioid withdrawal syndrome (NOWS) compared to those treated with methadone, with 38.7% versus 65.8% requiring treatment.

Buprenorphine/naloxone treatment was associated with a reduced need for multiple medications for NOWS and lower rates of fetal growth restriction, suggesting it may be a safer option for treating opioid use disorder during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of neonatal outcomes in pregnant women undergoing medication-assisted treatment of opioid use disorder with methadone or buprenorphine/naloxone. Petrich, M., Battin, M., Walker, E., et al.[2023]

Buprenorphine shows better or similar safety outcomes compared to methadone for treating neonatal abstinence syndrome (NAS), with fewer infants requiring treatment and shorter hospital stays, based on a review of 5 critical studies.

Both medications are effective for pregnant women with opioid dependence, but buprenorphine may be a preferable option due to its improved outcomes, although more extensive studies are needed to confirm its safety and advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine Versus Methadone for Opioid Dependence in Pregnancy. Noormohammadi, A., Forinash, A., Yancey, A., et al.[2018]

Maternal opioid use disorder (OUD) is increasingly common due to the opioid epidemic, and effective management typically includes opioid agonist treatments like methadone or buprenorphine, along with therapy and counseling.

Neonatal opioid withdrawal syndrome can occur in newborns of mothers with OUD, impacting their neurobehavioral functioning, and effective treatment relies heavily on nonpharmacologic comforting measures that require maternal involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors Associated with Perinatal Relapse to Opioid Use Disorder. Nawaz, N., Hester, M., Oji-Mmuo, CN., et al.[2022]

Infants exposed to buprenorphine alone had a significantly higher rate of neonatal abstinence syndrome (54.6%) compared to those exposed to the buprenorphine and naloxone combination (35.3%), suggesting that the combination product may be safer for fetal outcomes.

The study indicates that while the combined buprenorphine and naloxone product is associated with lower odds of neonatal abstinence syndrome, these results were not statistically significant after adjusting for other factors, indicating that both treatments are acceptable options for managing opioid use disorder during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine and Naloxone Versus Buprenorphine for Opioid Use Disorder in Pregnancy: A Cohort Study. Mullins, N., Galvin, SL., Ramage, M., et al.[2021]

In a study of 89 infants born to mothers on buprenorphine, 43.8% required morphine treatment for neonatal abstinence syndrome (NAS), with an average of 15.9 days on morphine and a 20-day hospital stay.

The study found that higher doses of buprenorphine did not increase the severity of NAS, and exclusive breastfeeding significantly reduced the likelihood of needing morphine treatment, indicating it is a safe and beneficial practice for these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Maternal Buprenorphine Dose Affect Severity or Incidence of Neonatal Abstinence Syndrome? Wong, J., Saver, B., Scanlan, JM., et al.[2019]

Buprenorphine treatment for pregnant women with opioid use disorder is associated with a lower risk of preterm birth and results in greater birth weight and larger head circumference compared to methadone, based on a review of 18 studies involving 2,146 participants.

There were no significant differences in rates of fetal death or congenital anomalies between the two treatments, suggesting that buprenorphine does not pose greater risks than methadone for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine compared with methadone to treat pregnant women with opioid use disorder: a systematic review and meta-analysis of safety in the mother, fetus and child. Zedler, BK., Mann, AL., Kim, MM., et al.[2023]

Infants born to mothers treated with buprenorphine/naloxone during pregnancy experienced neonatal abstinence syndrome less frequently (64%) compared to those born to mothers treated with methadone (80%), suggesting a potential safety advantage for buprenorphine/naloxone.

Both treatment groups showed similar neonatal outcomes in terms of gestational age, birth weight, and need for neonatal intensive care, indicating that neither medication led to significant adverse effects on newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal outcomes following in utero exposure to buprenorphine/naloxone or methadone. Gawronski, KM., Prasad, MR., Backes, CR., et al.[2022]

In a study of 609 opioid-dependent pregnant women, those treated with buprenorphine had better outcomes, including starting treatment earlier, longer gestation periods, and larger infants compared to those treated with methadone.

Newborns from mothers on buprenorphine required significantly less treatment for neonatal abstinence syndrome and for shorter durations, suggesting that buprenorphine may be a safer and more effective option for treating opioid dependence during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methadone and buprenorphine for opioid dependence during pregnancy: a retrospective cohort study. Meyer, MC., Johnston, AM., Crocker, AM., et al.[2022]

A study of 32 pregnant women undergoing buprenorphine treatment for opioid dependence revealed medium risk of abuse in their parenting skills, indicating potential issues like inappropriate expectations and low empathy towards their children.

Despite showing deficits in parenting skills, these women did not express significant concerns about their ability to parent, highlighting the need for targeted educational interventions to improve their parenting knowledge and address concerns about neonatal abstinence syndrome (NAS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting and concerns of pregnant women in buprenorphine treatment. Rizzo, RA., Neumann, AM., King, SO., et al.[2021]

In Illinois, a total of 89 treatment resources for opioid use disorder (OUD) in pregnant women were identified, but these resources were concentrated in only 36% of the counties, highlighting significant geographic disparities.

Counties with limited OUD treatment resources had higher rates of neonatal abstinence syndrome (NAS), with 66% of NAS cases in rural areas occurring in counties lacking any OUD treatment options, indicating a critical need for improved access to medication-assisted treatment (MAT) in these regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The interaction of neonatal abstinence syndrome and opioid use disorder treatment availability for women insured by medicaid. Reising, VA., Horne, A., Bennett, AC.[2021]

In a study of 108 pregnant women and mothers with young children undergoing buprenorphine maintenance treatment for opioid use disorder, 73.2% retained treatment after 12 months, indicating a relatively high retention rate.

Patients with a history of psychiatric treatment or misdemeanor convictions were less likely to remain in treatment, suggesting that these factors may require more intensive support and tailored interventions to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective analysis of treatment and retention outcomes of pregnant and/or parenting women with opioid use disorder. Lopian, KM., Chebolu, E., Kulak, JA., et al.[2020]

In a study of 62 mother-neonate pairs, neonates born to mothers treated with buprenorphine and naloxone had a significantly lower prevalence of neonatal abstinence syndrome (25.1%) compared to those born to mothers treated with methadone (51.6%).

Neonates exposed to buprenorphine and naloxone also experienced lower peak neonatal abstinence syndrome scores and shorter hospital stays, indicating a potentially safer and more effective treatment option during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine and naloxone compared with methadone treatment in pregnancy. Wiegand, SL., Stringer, EM., Stuebe, AM., et al.[2022]

Women with opioid use disorder (OUD) who were on opioid maintenance therapy (OMT) were more likely to continue treatment and maintain custody of their children, highlighting the effectiveness of OMT in supporting recovery.

In contrast, women enrolled in residential treatment programs during pregnancy were less likely to continue treatment or keep custody, suggesting that the type of treatment setting can significantly impact outcomes for mothers with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuation in Treatment and Maintenance of Custody of Newborns After Delivery in Women With Opioid Use Disorder. Schauberger, CW., Borgert, AJ., Bearwald, B.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035657/

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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2203318

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.

3. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/08/opioid-use-and-opioid-use-disorder-in-pregnancy

Opioid Use and Opioid Use Disorder in Pregnancy An inadequate maternal methadone dosage may result in mild to moderate opioid withdrawal signs and symptoms that may cause fetal stress and maternal drug ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00271219

RCT Comparing Methadone and Buprenorphine in ... Past research has shown that use of buprenorphine in pregnant women results in improved birth outcomes over methadone. The purpose of this study is to evaluate ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.14497

Buprenorphine‐naloxone, buprenorphine, and methadone ... Buprenorphine-naloxone seems to be as safe for pharmacotherapy for maternal opioid use disorder as buprenorphine monotherapy for both mother and newborn.

6. med.stanford.edu med.stanford.edu/news/all-news/2022/11/buprenorphine-pregnancy-opioid.html

Use of buprenorphine during pregnancy better for infants than ... Prior research suggested that buprenorphine may lead to better medical outcomes for infants of mothers with opioid use disorder than methadone.