CADENCE Program for Opioid Use Disorder in Pregnancy

(CADENCE Trial)

Overseen By Jennifer Marshall, PHD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Under 18, Incarcerated, Non-pregnant

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called CADENCE, which aims to improve care for pregnant women dealing with opioid use disorder (OUD). The goal is to gather better information on how OUD affects mothers and their babies, particularly since it can lead to serious health issues like neonatal withdrawal syndrome (NOWS). The trial seeks to find ways to integrate and enhance treatment options. Pregnant individuals diagnosed with OUD might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve care for future mothers and babies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the CADENCE program is safe for opioid use disorder in pregnancy?

Research has shown that programs combining substance use treatment during pregnancy can improve health for both mothers and babies. The CADENCE program is being tested as a new method to assist pregnant women with opioid use disorder (OUD). Although specific safety data for CADENCE is not yet available, similar programs have successfully improved health outcomes for mothers and their infants.

The CADENCE program uses information to guide care and support for pregnant women with OUD. This approach aims to provide ongoing support and may help prevent issues like neonatal withdrawal syndrome (NOWS), which can occur in newborns when mothers use opioids during pregnancy.

As the CADENCE program is still under research, detailed safety data is not yet available. However, the study's use of existing health information suggests it is designed to be safe and supportive. Participants in similar studies have generally responded well to these types of programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CADENCE program for opioid use disorder in pregnancy because it offers a comprehensive, tailored approach that goes beyond the standard treatments like methadone or buprenorphine. Unlike typical medication-based treatments, CADENCE focuses on integrating behavioral health support specifically designed for pregnant women struggling with opioid use. This holistic method aims to address not just the addiction, but also the unique psychological and social needs of pregnant participants, potentially leading to better outcomes for both mothers and their babies.

What evidence suggests that the CADENCE program is effective for opioid use disorder in pregnancy?

Research has shown that programs like the CADENCE program, piloted in this trial, include treatment for substance use disorder during pregnancy and yield positive results for both mothers and babies. In a study with 113 pregnant women with opioid use disorder, those who received medications like buprenorphine or methadone had successful live births. The CADENCE program seeks to enhance these outcomes by using local information to provide care tailored to the needs of both mother and baby. This approach is expected to reduce issues like neonatal withdrawal syndrome (NOWS), which can occur when babies are born after opioid exposure. By focusing on both medical and supportive care, CADENCE aims to improve the health of mothers and their newborns. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Marshall, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for pregnant individuals over the age of 18 who have been diagnosed with opioid use disorder. It's not open to those under 18, incarcerated individuals, non-pregnant people, or patients without an opioid use disorder.

Inclusion Criteria

I am over 18, pregnant, and have an opioid use disorder.

Exclusion Criteria

I am under 18 years old.

Patients who are incarcerated

Patients without opioid use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Care

Participants receive prenatal care and are monitored for OUD treatment and outcomes

Up to 40 weeks

Regular prenatal visits

Delivery Hospitalization

Participants are monitored for MOUD treatment and neonatal outcomes during delivery

At delivery

Hospital stay for delivery

Postnatal Follow-up

Participants and infants are monitored for health outcomes and program acceptability

Up to 1 year postpartum

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• CADENCE program

Trial Overview

The CADENCE program is being tested in this study. It aims to improve outcomes for mothers and infants affected by opioid use disorders by using public health and clinical data to inform care.

How Is the Trial Designed?

Group I: CADENCE program pilot Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

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]

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

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]

Buprenorphine-naloxone (Suboxone) was found to be safe and well tolerated for short-term opioid detoxification in a study involving 234 opioid-dependent patients across twelve community-based treatment programs.

The treatment showed high medication compliance (81% of doses ingested) and successful induction, with 90% of patients reaching the target dose within three days, indicating its efficacy and practicality in diverse settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. Amass, L., Ling, W., Freese, TE., et al.[2022]

In a study of 113 pregnant women with opioid use disorder, the majority were treated with either buprenorphine (52.2%) or methadone (47.8%), with a live birth rate of 90.8%, indicating that effective treatment can lead to positive pregnancy outcomes.

Despite the high prevalence of social challenges and substance use, opioid relapse rates were similar between those treated with buprenorphine and methadone (44.7% overall), highlighting the need for ongoing support and care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal Treatment and Outcomes of Women With Opioid Use Disorder. Brogly, SB., Saia, KE., Werler, MM., et al.[2021]

Only 13% of buprenorphine providers and 5% of opioid treatment programs are located in rural areas, highlighting significant geographic barriers for pregnant women seeking opioid agonist therapy in Missouri and Illinois.

While opioid treatment programs were more likely to accept new pregnant patients and had shorter wait times, the majority of buprenorphine providers required multiple contact attempts and had longer wait times, indicating a need for improved access and reliability in treatment options for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to accessing opioid agonist therapy in pregnancy. Bedrick, BS., O'Donnell, C., Marx, CM., et al.[2022]

Citations

1.

reporter.nih.gov

reporter.nih.gov/search/t-4Rr80AREi0yPHsgvp6jg/project-details/10590267

CADENCE - Continuous And Data-drivEN CarE

Single-site studies that integrate substance use disorder programs in pregnancy have been shown to improve neonatal and maternal outcomes. With that in mind ...

2.

withpower.com

withpower.com/trial/phase-opioid-related-disorders-9-2023-22610

CADENCE Program for Opioid Use Disorder in Pregnancy

In a study of 113 pregnant women with opioid use disorder, the majority were treated with either buprenorphine (52.2%) or methadone (47.8%), with a live birth ...

3.

cdc.gov

cdc.gov/mmwr/volumes/72/ss/ss7203a1.htm

Medication for Opioid Use Disorder During Pregnancy

From 1999 to 2014, the prevalence of opioid use disorder (OUD) among pregnant women in the United States quadrupled from 1.5 to 6.5 per 1,000 ...

4.

hd2arasc.org

hd2arasc.org/wp-content/uploads/2024/11/Unlocking-better-outcomes_-A-journey-mapping-approach-to-treating-opioid-use-disorder-in-pregnant-individuals-with-the-cadence-program.pdf

A journey mapping approach to treating opioid use ...

Care (CADENCE) program is to leverage high-quality local data to improve opioid use disorder OUD outcomes during and after pregnancy with an integrated care ...

5.

reporter.nih.gov

reporter.nih.gov/project-details/9656280

wen, xuerong - NIH RePORTER

Our results will help determine the role of perinatal opioid exposures on children development and provide evidences for improved perinatal care. NIH Spending ...

6.

hd2arasc.org

hd2arasc.org/innovation-and-acceleration-projects/cadence-continuous-and-data-driven-care/

CADENCE: Continuous and Data-Driven Care

An interactive data dashboard for maternal, neonatal, and infant outcomes for pregnancies affected by opioid use disorder.

7.

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

Opioid use in pregnancy has escalated dramatically in recent years, paralleling the epidemic observed in the general population.