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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07776457
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pregnancy
  • Substance Use Disorder (SUD)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Contingency Management — BEHAVIORAL
    12 weekly sessions, 15-20 minutes each
  • Social Drivers of Health Screening — OTHER
    Screening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Jan 31, 2027
Status verified
Aug 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
245 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Contingency Management
    Receiving social drivers screening, all standard clinical care, and contingency management
  • Active Comparator: Usual Care
    Receiving social drivers screening and all standard clinical care

Primary Outcome Measure

Number of participants with no unplanned 60-day gap in clinical care [ Time Frame: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington UniversitySt LouisMissouri63110
Melissa Mills, BS
[email protected]
(557) 234-9066
Jeannie C Kelly, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University· St Louis, MO

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