NCT05609669

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Aug 2023Sep 2027

First Submitted

Initial submission to the registry

November 2, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

August 23, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

3.4 years

First QC Date

November 2, 2022

Last Update Submit

November 5, 2025

Conditions

Pregnancy RelatedOpioid Use Disorder

Outcome Measures

Primary Outcomes (2)

  • MOUD at delivery hospitalization

    Patients on subutex or methadone treatment at delivery hospitalization (yes/no)

    At delivery hospitalization

  • Decreased pharmacologically treated NOWS

    Medication clinically required for NOWS (yes/no)

    At delivery

Secondary Outcomes (8)

  • First trimester entry to prenatal care

    Prenatal care, up to 40 weeks

  • Prenatal care adequacy

    Prenatal care, up to 40 weeks

  • Hepatitis C screening

    Prenatal care, up to 40 weeks

  • NICU admissions

    At delivery hospitalization

  • Hospital length of stay (neonate)

    At delivery hospitalization

  • +3 more secondary outcomes

Other Outcomes (3)

  • Acceptability of CADENCE Program

    Prenatal up to 1 year old

  • Feasibility of CADENCE Program

    Prenatal up to 1 year old

  • Trialability of CADENCE Program

    Prenatal up to 1 year old

Study Arms (1)

CADENCE program pilot

EXPERIMENTAL
Other: CADENCE program

Interventions

CADENCE programOTHER

The CADENCE program will consist of an integrated care pathway between the OBOT clinic, obstetric clinic, pediatric clinic, and behavioral health with multiple entry points, including emergency rooms, existing mobile harm reduction clinics, obstetric clinics, and delivery facilities. We also seek to provide wrap-around care for these families with peer support, care navigation, and robust community support, using existing Hillsborough County resources such as doula programs, Healthy Start, and other home visiting programs.

CADENCE program pilot

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known opioid use disorder over the age of 18 years old who are pregnant

You may not qualify if:

  • Patients without opioid use disorder, less than 18 years old, incarcerated, or non-pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida/Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jennifer Marshall, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 8, 2022

Study Start

August 23, 2023

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Quantitative data: The raw data at the individual level will be available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All data-sharing agreements must be approved by our institutional IRB and follow university protocols.

Access Criteria
Qualitative Data: The proposed research will include data from approximately 20 subjects. We will make the quantitative data, summary of qualitative data with representative quotes, and associated documentation available to users only under a specific data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Aggregate data and summary tables will be available through the NIH HEAL Initiative central data repository.

Locations

US(1)