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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the CADENCE treatment for opioid use disorder in pregnancy?

The research suggests that an interdisciplinary approach, including medication-assisted treatment with drugs like methadone or buprenorphine, is effective for pregnant women with opioid use disorder. These treatments improve outcomes for both mothers and babies, with buprenorphine showing better neonatal outcomes compared to methadone. ^{1 2 3 4 5}

Is the CADENCE Program treatment safe for humans?

The CADENCE Program involves treatments like buprenorphine, which has been shown to be safe for pregnant women with opioid use disorder. Studies indicate that transitioning pregnant women to buprenorphine or methadone is safe, with no significant differences in safety measures like fetal movement and maternal health indicators. ^{1 6 7 8 9}

How is the CADENCE treatment for opioid use disorder in pregnancy different from other treatments?

The CADENCE program is unique because it combines pharmacotherapy (medication treatment) with behavioral counseling and other supportive health behaviors, focusing on a comprehensive approach to improve both maternal and infant outcomes during pregnancy. ^{1 5 10 11 12}

What is the purpose of this trial?

The proposed project seeks to use public health and clinical data on opioid use disorders (OUD) outcomes for mother and infants, which is the leading cause of death to mothers one year after deliver and can lead to neonatal withdrawal syndrome (NOWS) and other poor outcomes. Insufficient or incomplete data about OUD and lack of integrated programs for OUD treatment during pregnancy can be barriers to providing optimal care to mothers and infants.

Research Team

Jennifer Marshall, MD

Principal Investigator

University of South Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]

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

Prenatal Treatment and Outcomes of Women With Opioid Use Disorder. [2021]

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

The interaction of neonatal abstinence syndrome and opioid use disorder treatment availability for women insured by medicaid. [2021]

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

A retrospective analysis of treatment and retention outcomes of pregnant and/or parenting women with opioid use disorder. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacological Management of Opioid Use Disorder in Pregnant Women. [2021]

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

Inpatient Buprenorphine Induction for Opioid Use Disorder in Pregnancy. [2023]

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

Barriers to accessing opioid agonist therapy in pregnancy. [2022]

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

Randomized controlled study transitioning opioid-dependent pregnant women from short-acting morphine to buprenorphine or methadone. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Bringing buprenorphine-naloxone detoxification to community treatment providers: the NIDA Clinical Trials Network field experience. [2022]

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

Obstetric management of women with opioid use disorder. [2020]

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

Treating opioid use disorders during pregnancy: historical, current, and future directions. [2015]

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

The MATernaL and Infant NetworK to Understand Outcomes Associated with Treatment of Opioid Use Disorder During Pregnancy (MAT-LINK): Surveillance Opportunity. [2021]