Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-31 @ 5:08 PM
Study NCT ID:
NCT06556602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-19
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methadone Patient Access to Collaborative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Hybrid Type 1, 18-month simultaneous cluster randomized controlled trial in 30 clinics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1080}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-15', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days in Treatment to treatment interruption', 'timeFrame': '18 months', 'description': 'Time (days) to treatment interruption'}, {'measure': 'Time to treatment cessation', 'timeFrame': '18 months', 'description': 'Time to treatment cessation (tolerance of 30 days)'}, {'measure': 'In Treatment- Point in time', 'timeFrame': '18 months', 'description': 'Point in time in treatment (0 day, 30 day, 60, day, 90 day)'}, {'measure': 'Number of patients reporting opioid overdoses while in methadone treatment', 'timeFrame': '18 months', 'description': 'Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.'}], 'secondaryOutcomes': [{'measure': 'Number of staff experiencing vicarious (work related) stress', 'timeFrame': '18 months', 'description': 'Post traumatic stress symptoms and vicarious (work related) trauma symptoms measured by the Vicarious Trauma Scale (VTS). Total scores can be grouped into three categories to represent low (8-28), moderate (29-42) and high (43-56) levels of vicarious trauma symptoms'}, {'measure': 'Number of patients and staff experiencing post traumatic stress symptoms', 'timeFrame': '18 months', 'description': 'Post traumatic stress symptoms measured by the 8-item PCL-5 measuring post traumatic stress symptoms. Scores range from 0-80, with higher scores representing greater levels of traumatic stress symptomatology.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methadone'], 'conditions': ['Opioid Use Disorder', 'Staff', 'Patients']}, 'referencesModule': {'references': [{'pmid': '40105313', 'type': 'DERIVED', 'citation': 'Meyerson BE, Davis A, Crosby RA, Linde-Krieger LB, Brady BR, Carter GA, Mahoney AN, Frank D, Rothers J, Coffee Z, Deuble E, Ebert J, Jablonsky MF, Juarez M, Lee B, Lorenz HM, Pava MD, Tinsely K, Yousaf S. Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes. JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829.'}]}, 'descriptionModule': {'briefSummary': 'The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.\n\nIt will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.', 'detailedDescription': 'This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:\n\nAIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.\n\nAIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.\n\nAIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Staff providing methadone treatment services at the enrolled opioid treatment programs\n\nExclusion Criteria:\n\n* Patients receiving methadone treatment at the enrolled opioid treatment programs'}, 'identificationModule': {'nctId': 'NCT06556602', 'acronym': 'MPACT', 'briefTitle': 'Methadone Patient Access to Collaborative Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Methadone Patient Access to Collaborative Treatment (MPACT)', 'orgStudyIdInfo': {'id': '456483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MPACT Intervention', 'description': 'Enrolled clinic staff will be exposed to the MPACT intervention components over the trial period. This includes accredited training, clinic self assessment, reflective supervision for counseling/peer/case management staff, and wellness education with navigation to trauma symptoms assessment and resources including trauma treatment. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.', 'interventionNames': ['Other: MPACT']}, {'type': 'NO_INTERVENTION', 'label': 'Control for MPACT', 'description': 'Enrolled clinic staff will not receive any portion of the intervention. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.'}], 'interventions': [{'name': 'MPACT', 'type': 'OTHER', 'description': 'Four components are part of this intervention: 1) accredited training about patient centered, trauma-informed care and the standard of care under the current federal regulation (42CFRpart8), 2) education about trauma and trauma symptoms including vicarious (work related) trauma and navigation to symptoms screening and resources including treatment, 3) reflective supervision for counseling, case management and peer staff, and 4) clinic self assessment for trauma-informed and patient centered care', 'armGroupLabels': ['MPACT Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85714', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona College of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Within 2 years of study completion', 'ipdSharing': 'YES', 'description': 'A Data Management and Sharing Plan has been filed with the National Institute on Drug Abuse.', 'accessCriteria': 'See Data Management and Sharing Plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}