protocolSection identificationModule nctId: NCT06307340, orgStudyIdInfo id: 22-01058, briefTitle: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors., conditionsModule conditions: Polysubstance Abuse, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: The data analyst is blinded to participant arm., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT), interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Proportion of Eligible Participants, primaryOutcomes measure: Proportion of Eligible Participants who Enroll, primaryOutcomes measure: Number of Intervention Sessions Completed, primaryOutcomes measure: Clinician-Rated Feasibility of Intervention Measure (FIM) Score, primaryOutcomes measure: Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score, primaryOutcomes measure: Number of Days of Co-Use of Cocaine and Illicit Opioids, primaryOutcomes measure: Number of Substances Used based on ASI Self-Report, primaryOutcomes measure: Number of Substances Used based on Urine Drug Screen, primaryOutcomes measure: Number of Substances Used based on Chart Abstraction of Toxicology Results, primaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5) Score, primaryOutcomes measure: Negative Mood Regulation Scale Score, primaryOutcomes measure: Inventory of Interpersonal Problems Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida State University, city: Tallahassee, state: Florida, zip: 32306, country: United States, contacts name: Tanya Renn, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.43826, lon: -84.28073, locations facility: START Treatment and Recovery Centers, city: Brooklyn, state: New York, zip: 11238, country: United States, contacts name: Ana Ventuneac, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.6501, lon: -73.94958, locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False