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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWashington University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Contingency Management

    Behavioral

    12 weekly sessions, 15-20 minutes each

  • Social Drivers of Health Screening

    Other intervention

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

Treatment groups

245 Participants
are divided into 2 treatment groups
Group A: Contingency ManagementExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Time frame
From date of randomization until 1 year postpartum or end of study, whichever comes first, up to 92 weeks
3

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

1

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
2

Number of patients randomized pregnant that have preterm birth

Preterm birth defined as live birth \<37 weeks, 0 days gestational duration

Time frame
After randomization, at delivery
3

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

Time frame
After randomization and delivery, during delivery admission, up to 1 month after delivery
4

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

Time frame
After randomization and delivery, during delivery admission

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

University of Maryland, Baltimore

Collaborator

This trial is not recruiting at the moment. You can still explore other options: