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NCT07776457
Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management
Conditions: Pregnancy, Substance Use Disorder (SUD)
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 245
Sponsor: Washington University School of Medicine
Location: Washington University St Louis Missouri
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07776457). StuddyBuddy aggregates publicly available trial information.