Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 11:58 PM
Study NCT ID:
NCT06513728
Status:
COMPLETED
Last Update Posted:
2025-08-08
First Post:
2024-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000068376', 'term': 'Compassion Fatigue'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D013315', 'term': 'Stress, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot implementation and preliminary effectiveness study of MPACT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'methadone treatment retention', 'timeFrame': '4 months (pilot study period)', 'description': 'Retention in methadone treatment (measured by 3 different indicators)'}, {'measure': 'In treatment overdose', 'timeFrame': '4 months (pilot study period)', 'description': 'Reported overdoses during methadone treatment (measured by study constructed algorithm)'}], 'secondaryOutcomes': [{'measure': 'Trauma symptoms among patients and staff', 'timeFrame': 'pilot period of 4 months', 'description': 'Post traumatic stress symptoms (measured by 8-item Post Traumatic Stress Disorder Checklist or, PCL-5). Scores are 0-80. Higher scores mean greater PTSD symptom severity.'}, {'measure': 'Vicarious Trauma symptoms among staff', 'timeFrame': 'pilot period of 4 months', 'description': 'Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Implementation Science', 'Methadone treatment', 'Opioid Use Disorder', 'Opioid Use Disorder Treatment', 'Workforce Development', 'Vicarious trauma', 'Posttraumatic stress', 'Treatment retention'], 'conditions': ['Opioid Substitution Treatment Clinics', 'Patients', 'Staff']}, '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': 'Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.', 'detailedDescription': 'Specific AIMS:\n\nAIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.\n\nAIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:\n\n1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.\n2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.\n3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.\n\nAIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment\n* Patients receiving methadone at these locations\n\nExclusion Criteria:\n\n* Patients not receiving methadone at these locations\n* Staff not involved in methadone treatment at these locations'}, 'identificationModule': {'nctId': 'NCT06513728', 'acronym': 'MPACT', 'briefTitle': 'Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Methadone Patient Access to Collaborative Treatment', 'orgStudyIdInfo': {'id': '456482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MPACT Intervention', 'description': 'Single arm study. All sites will receive the intervention.', 'interventionNames': ['Other: MPACT Intervention']}], 'interventions': [{'name': 'MPACT Intervention', 'type': 'OTHER', 'description': 'MPACT has 4 components: accredited training about patient centered, trauma informed methadone treatment, staff education about trauma symptoms with navigation to self screening and treatment or stress management, clinic self assessment tools for trauma informed, patient centered care, and reflective supervision for counselors, case managers and peer staff.', '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}}], 'overallOfficials': [{'name': 'Beth Meyerson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': '1 year after the study completion', 'ipdSharing': 'YES', 'description': 'A Data Sharing and Management Plan was submitted to NIDA for this study. please see that submission.', 'accessCriteria': 'See Data sharing and management plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}