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Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management

NCT07776457 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-08-20

No results posted yet for this study

Summary

Overdose is a national top-three leading cause of pregnancy-associated death, and maternal substance use disorder (SUD) accounts for an estimated $1.5 billion in healthcare spending each year. Treatment with medication and behavioral therapy lowers morbidity and overdose risk. However, studies have shown 55% to 80% of patients stop treatment within one year postpartum. Additionally, as a result of systemic inequities, historically marginalized patients are at greatest risk of overdose or death. We are conducting a study at WashU Medicine and University of Maryland, Baltimore clinics that offer prenatal care, addiction treatment, and extended postpartum support for patients facing the challenges of a SUD. Study participants will complete a structured screening and management of their social needs, and then will be randomly assigned to continue their usual care or to participate in a contingency management program, which provides incentives to continue treatment.

Conditions

  • Pregnancy
  • Substance Use Disorder (SUD)

Interventions

BEHAVIORAL

Contingency Management

12 weekly sessions, 15-20 minutes each

OTHER

Social Drivers of Health Screening

Screening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage

Sponsors & Collaborators

Principal Investigators

  • Jeannie C Kelly, MD, MS · Washington University School of Medicine

  • Ana A Baumann, PhD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2030-02-28
Completion
2030-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776457 on ClinicalTrials.gov