[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650204":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":34,"responsibleParty":41,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":34,"enrollmentInfo":59,"targetDuration":34,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":34},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FIT TAU","ACTIVE_COMPARATOR","Formerly Incarcerated Transitions (FIT) program engagement treatment-as-usual (TAU). As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. All participants will also receive referrals to behavioral health services in the community.",[13],"Behavioral: Formerly Incarcerated Transitions Program",{"label":15,"type":16,"description":17,"interventionNames":18},"FIT + IT-BA","EXPERIMENTAL","Formerly Incarcerated Transitions (FIT) program engagement with an Individually Tailored Behavioral Activation (IT-BA) intervention. As part of the FIT program, all participants will be linked with a community health worker with lived experience of incarceration who provides peer support and coordinates care. IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and\u002For teletherapy appointments. All participants will also receive referrals to behavioral health services in the community.",[19,13],"Behavioral: Individually Tailored Behavioral Activation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Individually Tailored Behavioral Activation","IT-BA is an individually tailored, low-barrier version of Behavioral Activation (BA) that was adapted by Dr. Paquette and has demonstrated preliminary efficacy among people who use drugs (PWUD). IT-BA will be delivered in 12 sessions over 8 weeks in a low-barrier, flexible hybrid format with the option of in-person and\u002For teletherapy appointments.",[15],[27],"IT-BA",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Formerly Incarcerated Transitions Program","The FIT program provides integrated medical care enhanced with peer support and linkage to care for individuals who have been incarcerated within the past year and have at least one chronic health condition, including substance use disorders. After the intake assessment, which includes evaluation of medical and psychosocial needs, community health workers (CHWs) provide peer support and help connect patients to appropriate services at FIT clinic sites and in the community based on their individual needs and goals. CHWs also assist with transportation to\u002Ffrom appointments and may provide smartphones with cellular and internet service to facilitate engagement in care. All FIT patients are also assigned a FIT primary care provider (with appointments coordinated by the CHW), and patients with opioid use disorder are offered an appointment with an MOUD provider. After initial coordination of care, CHWs maintain contact with FIT patients as needed to provide ongoing support",[15,9],[33,9],"FIT",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Catherine Paquette, PhD","CONTACT","+1 919-681-6801","catherine.paquette@duke.edu",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Catherine E. Paquette, PhD","Assistant Professor, Dept of Population Health Sciences",[46],{"name":47,"class":48},"National Institute on Drug Abuse (NIDA)","NIH","100650204","supportive-treatment-with-enhanced-post-incarceration-services-100650204",false,"NCT07744841","Supportive Treatment With Enhanced Post-Incarceration Services","Individually Tailored Behavior Therapy for Post-Incarceration Drug Use in Reentry Primary Care","STEPS","Inclusion Criteria:\n\n* Be aged 18 years or older\n* Have recent illicit drug use, defined as use of any illegal drug in the past week\n* Meet DSM-5 criteria for a current (past 12 months) substance use disorder associated with any illegal drug\n* Have been released from jail or prison (at least 30 consecutive days incarcerated) within the past year\n\nExclusion Criteria:\n\n* Currently engaged in psychosocial treatment for drug use\n* Unable to speak and understand English\n* Unable to provide informed consent, including people with severe mental illness requiring immediate treatment or with mental illness limiting their ability to participate (e.g., dementia)","ALL","18 Years",{"count":60,"type":61},120,"ESTIMATED","INTERVENTIONAL",[64],"NA","This study aims to improve health outcomes for people who use drugs after release from incarceration, a period of high risk for overdose and other adverse outcomes. It will examine an individually tailored behavioral activation (IT-BA) intervention integrated into a reentry primary care program with peer support. The goal is to reduce substance use, improve mental health, and increase engagement in healthcare.",[67],"Substance Use Disorders (SUDs)",[69,70,71,72,73,74,75,76,77],"Incarceration","Reentry","Peer Support","Addiction","Drug Use","Primary Care","Community Health Workers","Behavioral Activation","Behavior Therapy","NOT_YET_RECRUITING","2026-07-29",{"date":81,"type":82},"2026-08-04","ACTUAL",{"date":84,"type":61},"2026-12-01",{"date":86,"type":61},"2030-06-30",{"name":43,"class":6}]