Behavioral Intervention for Opioid Use Disorder During Pregnancy

Overseen By Sara Witcraft

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Medical University of South Carolina

Must be taking: Buprenorphine

Disqualifiers: Multiples, High-risk pregnancy, Psychosis, 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: 61

Duration: 5-9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help pregnant individuals manage opioid use disorder using therapy and a mobile app. It aims to determine if these tools can reduce anxiety and improve sleep, facilitating adherence to buprenorphine treatment, a medication for opioid use disorder. Participants will attend therapy sessions during and after pregnancy and use the app to support their treatment. This trial may suit those in the U.S. who are pregnant, less than 33 weeks along, and prescribed buprenorphine for opioid use disorder. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must have a confirmed prescription for buprenorphine products to participate.

What prior data suggests that this protocol and mobile application are safe for pregnant individuals with opioid use disorder?

Research has shown that medication to treat opioid use disorder (MOUD) during pregnancy is both common and recommended. It reduces the risk of relapse and supports better health for both mother and baby. Studies indicate that about 79% of pregnant individuals with opioid use disorder use MOUD, highlighting its widespread acceptance.

The current trial tests a new approach that combines therapy sessions with a mobile app to assist with medication use and therapy skills. Although specific safety data on this new method is not yet available, researchers aim to understand its effectiveness and ensure its safety for participants.

Overall, existing research generally considers MOUD treatments during pregnancy safe and well-tolerated. However, the new behavioral and digital support tools are still under study for their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EMPWR intervention because it offers a unique approach to managing opioid use disorder during pregnancy. Unlike standard treatments that primarily focus on medication like buprenorphine or methadone, EMPWR combines a telemedicine-based behavioral intervention with a supportive mobile app. This dual approach aims to reduce anxiety and improve sleep, which are often overlooked in traditional care, while also using technology to enhance medication adherence and therapy skills. By addressing these additional factors, EMPWR has the potential to improve outcomes for both mothers and their babies.

What evidence suggests that this behavioral intervention and mobile application are effective for opioid use disorder during pregnancy?

Research has shown that longer use of medication for opioid use disorder (OUD) during pregnancy improves health outcomes for both mothers and babies. Studies have found that pregnant women with OUD are more likely to receive medication treatments like buprenorphine than non-pregnant women. Many patients report that receiving OUD treatment during pregnancy is positive and helpful. This trial will evaluate the EMPWR intervention, which combines addiction treatment with pregnancy care, potentially enhancing the use of these services from pregnancy through the postpartum period. These findings suggest that supportive methods, including technology and therapy, could help pregnant individuals manage OUD effectively. ^{3 6 7 8 9}

Who Is on the Research Team?

Sara Witcraft

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for pregnant individuals in South Carolina, up to 27 weeks gestation, aged 18-45 with a history of opioid use disorder (OUD) within the past three years. They must have a prescription for buprenorphine products like Suboxone or Subutex to manage OUD and be able to participate throughout the study.

Inclusion Criteria

I am prescribed Suboxone, Subutex, or Zubsolv for opioid use disorder.

Living in South Carolina for the duration of the study period

I am pregnant and not more than 27 weeks along.

Exclusion Criteria

High-risk pregnancies including hyperemesis, hypertensive disorders of pregnancy, preterm labor or preterm birth in prior pregnancy, uterine anomaly, placenta previa, or vaginal bleeding in current pregnancy after the first trimester

Carrying multiples

Current psychotic symptoms and/or active suicidal intent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a technology-enhanced behavioral intervention and use a mobile application to improve buprenorphine retention and adherence during pregnancy

5-9 months

Four 60-minute therapy appointments during pregnancy, four 30-minute therapy appointments postpartum

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completing questionnaires and medication counts

3 months postpartum

Questionnaires at enrollment, 1-month postpartum, and 3-months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder

Trial Overview

The study tests a technology-enhanced behavioral intervention aimed at helping pregnant people stay on buprenorphine treatment. It includes biweekly therapy sessions during pregnancy, monthly postpartum sessions, and use of a mobile app designed to support their treatment journey.

How Is the Trial Designed?

Group I: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder Experimental Treatment 1 Intervention

EMPWR is a two-pronged intervention model comprised of 1) a provider-driven, telemedicine-based behavioral intervention to mitigate anxiety sensitivity and sleep deficiency and enhance peripartum buprenorphine retention, and 2) an adjunctive mobile application to promote patients' buprenorphine adherence and use of therapy skills learned through the behavioral intervention. The EMPWR therapy protocol is comprised of five 30-60-minute sessions delivered weekly or biweekly by a therapist during the second and/or third trimester of pregnancy, and three 30-minute booster sessions delivered months 1-3 postpartum.

Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder is already approved in United States, European Union for the following indications:

Approved in United States as Buprenorphine for:

• Opioid use disorder
• Severe pain

Approved in European Union as Buprenorphine for:

• Opioid dependence
• Severe pain

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 230 pregnant women, those treated with naltrexone for opioid use disorder had a significantly lower rate of neonatal abstinence syndrome (8.4%) compared to those treated with methadone or buprenorphine (75.2%), indicating naltrexone's potential efficacy in this population.

Naltrexone was well-tolerated by both mothers and fetuses, with no cases of neonatal abstinence syndrome observed in infants born to mothers who maintained naltrexone treatment until delivery, suggesting it is a safe option for managing opioid use disorder during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of naltrexone in treating opioid use disorder in pregnancy. Towers, CV., Katz, E., Weitz, B., et al.[2023]

Two case studies of pregnant patients with opioid use disorder (OUD) who switched from sublingual buprenorphine to monthly injections of Sublocade® showed no adverse outcomes for either the mothers or their babies, suggesting potential safety in this treatment during pregnancy.

Both patients maintained positive urine drug screens for buprenorphine throughout their pregnancies without experiencing withdrawal symptoms or birth anomalies, indicating that Sublocade may be a viable option for managing OUD in pregnant women, although further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. Towers, CV., Deisher, H.[2022]

Buprenorphine is an opioid medication used for treating opioid dependence and managing moderate to severe pain, and it can be prescribed to pregnant women as part of their treatment for opioid addiction.

The chapter details a method for quantifying buprenorphine and its metabolite norbuprenorphine in meconium using liquid chromatography tandem mass spectrometry (LC-MS/MS), which is important for monitoring drug exposure in newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitation of Total Buprenorphine and Norbuprenorphine in Meconium by LC-MS/MS. Marin, SJ., McMillin, GA.[2016]

A systematic review of 5 studies involving 1875 mother-baby pairs found that pregnant women treated with buprenorphine-naloxone for opioid use disorder did not experience serious adverse maternal or neonatal outcomes.

Compared to other opioid agonist treatments, women using buprenorphine-naloxone had neonates who were less likely to require treatment for neonatal abstinence syndrome, with no significant differences in other pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone use in pregnancy: a systematic review and metaanalysis. Link, HM., Jones, H., Miller, L., et al.[2021]

Buprenorphine (BUP) pharmacokinetics in pregnant women show that maximum concentrations of BUP and its metabolite norbuprenorphine (NBUP) tend to be lower during pregnancy compared to postpartum levels, indicating potential changes in drug metabolism during gestation.

The study suggests that upward dose adjustments of buprenorphine may be necessary as pregnancy progresses, similar to what is observed with methadone, to maintain effective treatment for opioid dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary buprenorphine sublingual tablet pharmacokinetic data in plasma, oral fluid, and sweat during treatment of opioid-dependent pregnant women. Concheiro, M., Jones, HE., Johnson, RE., et al.[2021]

In a study of 64 pregnant women with opioid use disorder, 64% were adherent to buprenorphine treatment, while 23% were non-adherent, indicating a significant challenge in maintaining treatment during pregnancy.

Non-adherent women experienced more severe opioid withdrawal symptoms and were prescribed lower doses of buprenorphine, suggesting that adherence is crucial for effective management of opioid use disorder in pregnant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine medication-assisted treatment during pregnancy: An exploratory factor analysis associated with adherence. Coker, JL., Catlin, D., Ray-Griffith, S., et al.[2020]

In a study involving 30 female rats, low-dose buprenorphine (BUP-LD) exposure during pregnancy showed relatively safe outcomes, with only minor effects on maternal care and offspring development, such as delayed growth and reduced body weight.

In contrast, high-dose buprenorphine (BUP-HD) significantly harmed maternal caregiving and offspring survival, leading to increased instances of Neonatal Opioid Withdrawal Syndrome (NOWS), highlighting the risks associated with overexposure during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational buprenorphine exposure: Effects on pregnancy, development, neonatal opioid withdrawal syndrome, and behavior in a translational rodent model. Wallin, CM., Bowen, SE., Roberge, CL., et al.[2020]

In a study of 106 pregnant individuals, those treated with buprenorphine-naloxone (BUP-NX) did not show a higher risk of returning to opioid use compared to those treated with buprenorphine (BUP).

There was also no significant difference in the need for pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS) between the BUP-NX and BUP groups, suggesting that BUP-NX is a safe option during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone Versus Buprenorphine for Treatment of Opioid Use Disorder in Pregnancy. Perry, BN., Vais, S., Boateng, JO., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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sciencedirect.com

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Medication for Opioid Use Disorder During Pregnancy

Among the 5,541 reported pregnancies at the seven clinical sites, 4,381 (79.1%) included persons who received MOUD (i.e., receipt of ...