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NCT Number: NCT07776457

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

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.

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Key information

Conditions

Pregnancy Chemically-Induced Disorders Mental Disorders Substance Use Disorder (SUD) Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Washington University

St Louis, Missouri, 63110, United States

Location contact

Jeannie C Kelly, MD, MS

PRINCIPAL_INVESTIGATOR

Melissa Mills, BS

CONTACT

[email protected]

(557) 234-9066

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed viable intrauterine pregnancy at any gestational age; OR postpartum with at least six months remaining until 365 days after deliver
Diagnosis of SUD as defined by DSM-5 and/or as documented in the clinical record
18 years of age or older
Two or more positive domains in first screening for social drivers of health
Receiving ongoing care at participating study site

Exclusion criteria

Declining follow-up care at participating study site
Participated in R61 pilot study for CM
Requiring immediate hospitalization for unstable medical or psychiatric conditions making patient clinically unsuitable for research participation at the time of enrollment approach
Unable to participate in English

Treatment and study plan

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

Primary outcomes

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
Median number of days until time to loss to follow-up

Time frame: From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks

Median number of days until loss to follow-up defined as unplanned 60-day gap in clinical care
Number of Urine Drug Screen (UDS) positive for prescribed Medication for Opioid Use Disorder (MOUD)

Time frame: Randomization through 1 year postpartum or end of study, whichever comes first, up to 92 weeks

Secondary outcomes

Number of urine drug screen (UDS) negative for non prescribed substances

Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of patients randomized pregnant that have preterm birth

Time frame: After randomization, at delivery

Preterm birth defined as live birth <37 weeks, 0 days gestational duration
Number of liveborn opioid exposed infants receiving pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome

Time frame: After randomization and delivery, during delivery admission, up to 1 month after delivery

Pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome (NOWS), among opioid exposed infants delivered by patients pregnant at randomization
Number of infants admitted to NICU

Time frame: After randomization and delivery, during delivery admission

Infant admitted to the neonatal intensive care unit for any length of time after delivery during delivery admission, among patients pregnant at randomization
Median number of days of NICU Length of Stay

Time frame: After randomization and delivery, during delivery admission, until delivery admission discharge, an average of two weeks

Length of hospital admission in the NICU in days, among infants admitted to NICU
Median number of maternal hospital admissinons to inpatient service

Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks

Number of hospital admissions to inpatient service (excluding delivery admission, ED and triage visits)
Number of participants with overdose

Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks

Documented overdose in medical record or by patient self-report
Number of maternal deaths

Time frame: Randomization through 1 year postpartum or study end, whichever comes first, up to 92 weeks
Number of participants with custody of infant at hospital discharge

Time frame: At infant discharge from delivery admission, an average of two weeks

Custody of infant at hospital discharge , among patients pregnant at randomization
Count of participants reporting each child custody scenario

Time frame: 6 months post randomization

Options: full custody of all children, full custody of some children, full custody of no children, N/A

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Diveley, RN, BSN

CONTACT

[email protected]

(314) 362-4685

Melissa Mills

CONTACT

[email protected]

(557) 234-9066

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

University of Maryland, Baltimore

Registry information

Official study title

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

Acronym: SUPPORT MOM

Important dates

Study start: 2027
Primary completion: 2030
Study completion: 2030
First posted: Aug 20, 2026
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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