[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07104123":3,"trial-entities:NCT07104123":134,"trial-summary:NCT07104123":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":68,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":123,"overall_officials":128,"references":132,"see_also_links":133},"NCT07104123","R61DA062321","Substance Use in Pregnancy - Optimizing Retention in Treatment","Substance Use in Pregnancy - Optimizing Retention in Treatment by Maximizing Opportunities for Management","RECRUITING","2027-09","2026-08","2026-08-10","2026-02-02","Washington University School of Medicine","OTHER",false,"Substance use during pregnancy is a leading cause of maternal morbidity and mortality in the United States, with 55-80% of postpartum patients disengaging from substance use disorder (SUD) treatment within one year of delivery. Structural and social determinants of health, including housing instability, transportation barriers, and limited childcare access, further exacerbate disparities in treatment retention.\n\nThis pilot study, conducted in two specialized prenatal care clinics, evaluates the feasibility and acceptability of two integrated strategies to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods. Aim 1 implements a standardized social needs screening and referral protocol to connect patients with community-based supports. Aim 2 pilots a contingency management intervention to incentivize recovery-supportive behaviors.\n\nFindings will inform the design of a larger multi-site randomized controlled trial to evaluate the impact of these interventions on treatment retention, overdose prevention, and maternal-infant health outcomes.","Substance use during pregnancy remains a significant public health concern and is among the leading causes of maternal morbidity and mortality in the United States. Despite the availability of evidence-based interventions-including pharmacotherapy and behavioral counseling-treatment discontinuation in the postpartum period remains prevalent. Data from prior studies indicate that between 55% and 80% of postpartum patients disengage from substance use disorder (SUD) treatment within the first year following delivery. Disparities in treatment retention are further exacerbated by structural and social determinants of health, such as housing instability, transportation barriers, and limited access to childcare.\n\nThis pilot study is conducted in two specialized prenatal care clinics for individuals with SUD. The primary objective is to evaluate the feasibility and acceptability of two integrated, patient-centered strategies designed to promote sustained engagement in recovery-oriented services during the perinatal and postpartum periods.\n\nAim 1: Implementation of a Standardized Social Needs Screening and Referral Protocol This aim assesses the feasibility of deploying a structured, clinic-based protocol to systematically identify and address unmet social needs among pregnant patients with SUD. The protocol includes referral pathways to community-based services, including but not limited to perinatal home visiting programs, doulas, housing assistance, and transportation resources. Approximately 20 patients receiving care in the CARE clinic are enrolled to evaluate the clarity, usability, and clinical integration of the screening and referral process.\n\nAim 2: Pilot Testing of a Contingency Management Intervention This aim pilots a contingency management framework to incentivize engagement in recovery-supportive behaviors, such as attending scheduled appointments, adhering to treatment plans, and participating in supportive health activities. Contingency management demonstrates efficacy in other populations but has not been sufficiently adapted for use in perinatal SUD treatment settings. Approximately 20 patients are enrolled in this arm to assess the feasibility, fidelity, and preliminary acceptability of the intervention.\n\nBoth components of the study are designed to enhance long-term maternal recovery outcomes by delivering tailored, real-world supports that extend beyond delivery into the vulnerable postpartum period. Insights gained from this pilot study inform the development of a larger, multi-site randomized controlled trial to rigorously evaluate the impact of the interventions on treatment retention, overdose risk reduction, and maternal-infant health outcomes.",[19,20,21,22],"Substance Use Disorder (SUD)","Pregnancy","Postpartum","Contingency Management",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},40,"ESTIMATED",[32,36],{"type":14,"name":33,"description":34,"armGroupLabels":35},"Social drivers of health screening","Patients will undergo a structured and protocoled screening for social drivers of health and be linked to support services",[33],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Patients will undergo a program of contingency management","Patients will enter into a 12 week program of contingency management",[22],[42,46,50,53,57,60,64,66],{"measure":43,"description":44,"timeFrame":45},"Social Drivers: Enrollment","Percentage of eligible patients enrolled in the study","Enrollment Visit",{"measure":47,"description":48,"timeFrame":49},"Social Drivers: Screening","Percentage of visits for enrolled patients with social drivers of health screening","Through study completion, up to six months postpartum",{"measure":51,"description":52,"timeFrame":49},"Social Drivers: Documentation of Z-codes","Percentage of social driver screenings with z-codes documented",{"measure":54,"description":55,"timeFrame":56},"Contingency Management: Intervention Fidelity (Number of Visits)","Number of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist","Weekly from enrollment up to 12 weeks",{"measure":58,"description":59,"timeFrame":56},"Contingency Management: Intervention Fidelity (Percentage of Visits)","Percentage of CM sessions with fidelity to intervention, defined as meeting all six criteria on weekly CM visit checklist",{"measure":61,"description":62,"timeFrame":63},"Contingency Management: Acceptability of Intervention Measure (AIM)","Weiner et al, Implement Sci, 2017","After 3 CM sessions (up to 3 weeks), end of intervention (up to 12 weeks)",{"measure":65,"description":62,"timeFrame":63},"Contingency Management: Intervention Appropriateness Measure (IAM)",{"measure":67,"description":62,"timeFrame":63},"Contingency Management: Feasibility of Intervention Measure (FIM)",[69,73],{"measure":70,"description":71,"timeFrame":72},"Social Drivers: Frequency of Z-Codes","Frequency of of z-codes documented for each patient","End of intervention (up to 12 weeks postpartum)",{"measure":74,"description":75,"timeFrame":72},"Social Drivers: Percentage of Patients with Referrals","Percentage of patients with referrals to support services","FEMALE","18 Years",null,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"Inclusion Criteria:\n\nConfirmed viable intrauterine pregnancy at any gestational age, or within three years postpartum\n\nSUD as defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders or clinician documentation\n\nExclusion Criteria:\n\nDecline follow-up care at study site\n\nRequire immediate hospitalization for unstable medical or psychiatric conditions making them clinically unsuitable to participate in a research study",[84,85],"ADULT","OLDER_ADULT",[87,106],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":103},"University of Maryland","NOT_YET_RECRUITING","Baltimore","Maryland","21201","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Makeda Turner","CONTACT","443-328-4738","Makeda.Turner@som.umaryland.edu",{"name":101,"role":102},"Courtney Townsel, MD, MSc","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},39.29038,-76.61219,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":93,"contacts":111,"geoPoint":120},"Washington University","St Louis","Missouri","63108",[112,116,118],{"name":113,"role":97,"phone":114,"email":115},"Melissa Mills","314-273-2279","melissa.mills@wustl.edu",{"name":117,"role":102},"Jeannie C Kelly, MD, MS",{"name":119,"role":102},"Ana Baumann Walker, PhD",{"lat":121,"lon":122},38.62727,-90.19789,[124,126],{"name":125,"role":97,"phone":114,"email":115},"Melissa M Mills, BS",{"name":117,"role":97,"email":127},"jckelly@wustl.edu",[129,130],{"name":117,"affiliation":13,"role":102},{"name":131,"affiliation":13,"role":102},"Ana Baumann Walker, PhD, MA",[],[],{"nct_id":4,"conditions":135,"biomarkers":138},[136,20,137],"Disorder of puerperium","Substance use disorder",[],{"nct_id":4,"found":140,"summary":141,"prompt_version":151},true,{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an interventional pilot study, meaning participants will receive specific interventions. It plans to enroll 40 women who are pregnant or recently postpartum.","completed","Optimizing Treatment for Substance Use in Pregnant and Postpartum Individuals","This study aims to improve how pregnant and postpartum individuals with substance use disorder (SUD) stay engaged in treatment. It will test two approaches: screening for social needs (like housing or transportation) and connecting you to support services, and a 12-week program called contingency management (which uses rewards to encourage positive behaviors). Researchers want to see if these strategies are practical and acceptable. You may be eligible if you are 18 or older, pregnant or up to three years postpartum, and have a diagnosed SUD. The study plans to enroll 40 participants and is currently evaluating how well these methods work to address social needs.","Your social drivers of health will be screened and documented through study completion, up to six months postpartum.",105,"You will undergo screening for social drivers of health and be linked to support services, and participate in a 12-week contingency management program.","Not stated in the trial record.",[],"v2"]