About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Contingency Management
Behavioral12 weekly sessions, 15-20 minutes each
Social Drivers of Health Screening
Other interventionScreening for social drivers of health, documentation of applicable z-codes in the medical record and social needs linkage
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with no unplanned 60-day gap in clinical care
Median number of days until time to loss to follow-up
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)
Secondary outcomes
Number of urine drug screen (UDS) negative for non prescribed substances
Number of patients randomized pregnant that have preterm birth
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
Pharmacologic treatment for Neonatal Opioid Withdrawal Syndrome (NOWS), among opioid exposed infants delivered by patients pregnant at randomization
Number of infants admitted to NICU
Infant admitted to the neonatal intensive care unit for any length of time after delivery during delivery admission, among patients pregnant at randomization
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
University of Maryland, Baltimore
Collaborator
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