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

26 Participants Needed

Trial Summary

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 data supports the idea that Behavioral Intervention for Opioid Use Disorder During Pregnancy is an effective treatment?

The available research shows that buprenorphine, a drug used in Behavioral Intervention for Opioid Use Disorder During Pregnancy, is being studied for its effectiveness in treating pregnant women with opioid dependence. One study compared the outcomes of pregnant women treated with buprenorphine-naloxone to those treated with other medications, suggesting that buprenorphine can be a viable option. Another study looked at different forms of buprenorphine, like sublingual tablets and extended-release injections, indicating that there are multiple ways to administer the drug effectively. While specific outcome data is not provided, the research implies that buprenorphine is a promising treatment option for managing opioid use disorder during pregnancy. ^{1 2 3 4 5}

What safety data is available for buprenorphine treatment during pregnancy?

The safety data for buprenorphine treatment during pregnancy includes various studies and analyses. Buprenorphine is used to treat opioid dependence in pregnant women, and its effects have been studied in different forms, such as sublingual tablets and subcutaneous extended-release injections. A systematic review and meta-analysis compared pregnancy outcomes for women treated with buprenorphine-naloxone versus other medication-assisted treatments. However, there is limited data on the use of specific formulations like Sublocade during pregnancy. Research also includes pharmacokinetic studies and animal models to understand the impact of gestational exposure on pregnancy and offspring development. ^{1 3 4 5 6}

Is the drug buprenorphine a promising treatment for opioid use disorder during pregnancy?

Yes, buprenorphine is considered a promising drug for treating opioid use disorder during pregnancy. It is used as part of medication-assisted treatment to help manage addiction and has been prescribed to pregnant women to support their recovery. ^{3 4 5 7 8}

What is the purpose of this trial?

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.

Research Team

Sara Witcraft

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

I am pregnant and not more than 27 weeks along.

Living in South Carolina for the duration of the study period

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone use in pregnancy: a systematic review and metaanalysis. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone Versus Buprenorphine for Treatment of Opioid Use Disorder in Pregnancy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Preliminary buprenorphine sublingual tablet pharmacokinetic data in plasma, oral fluid, and sweat during treatment of opioid-dependent pregnant women. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitation of Total Buprenorphine and Norbuprenorphine in Meconium by LC-MS/MS. [2016]

6. Ireland pubmed.ncbi.nlm.nih.gov

Gestational buprenorphine exposure: Effects on pregnancy, development, neonatal opioid withdrawal syndrome, and behavior in a translational rodent model. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Use of naltrexone in treating opioid use disorder in pregnancy. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Buprenorphine medication-assisted treatment during pregnancy: An exploratory factor analysis associated with adherence. [2020]