Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-02-02 @ 12:02 PM
Study NCT ID:
NCT02617628
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2015-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624616', 'term': 'vivitrol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wswatson@upenn.edu', 'phone': '215-573-6707', 'title': 'W. Stuart Watson', 'organization': 'University of Pennsylvania Office of Research Services'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years, 2 months', 'description': 'The definition is the same as clinicaltrials.gov.\n\nCollection:\n\nMedical staff evaluated the intensity, seriousness, and causal relationship of the AE to study medication and procedures. The research medical staff asked the participant what adverse events have occurred since the last visit. Medical Staff evaluated for relatedness to study interventions. If serious, IRBs were notified in 5 days and followed up to determine its outcome.', 'eventGroups': [{'id': 'EG000', 'title': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months\n\nExtended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 35, 'seriousNumAtRisk': 74, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months\n\nExtended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 21, 'seriousNumAtRisk': 72, 'deathsNumAffected': 3, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'anxiousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'back pain-lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'nose bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'blurry vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'achey joints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'allergy in left eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'arthritis in leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'body aches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'chest pain-cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'breathing problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'wrist pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'nausea with vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'decreased sex drive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'fibrois mass on ovary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'increased urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'hip and left femor ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'infected boil', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'heart burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'insect bite swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'accidental inury, arm and knuckle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'excessive sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'withdrawn feeling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'hernia pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'hip arthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'hot-cold sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'irritable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'lethargic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'miscarriage of pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'muscle ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'restless', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'breathing abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'kidney pain', 'notes': 'kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'broken rib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relapse to Opioid Use in Subjects by Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.\n\nintensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.'}, {'id': 'OG001', 'title': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), After they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.\n\noutpatient treatment for six months. Subjects also received weekly psychosocial counseling.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '0.57', 'ciUpperLimit': '4.27', 'estimateComment': 'Threshold for significance was set at p\\<.05', 'groupDescription': 'Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks (month 3)', 'description': 'Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In treatment arm 1 (before reentry) 38 subjects received vivitrol before leaving prison.\n\nIn treatment arm 2 (after reentry) 48 subjects were eligible to receive injections after release from prison. Arm 2 subjects were to return to the research clinic within 7 days after release to receive their first injection.'}, {'type': 'SECONDARY', 'title': 'Reincarceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.'}, {'id': 'OG001', 'title': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74486', 'groupDescription': 'We used Cox proportional hazards regression model to compare the groups on time to reincarceration.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0 to 28 months', 'description': 'percentage of patients who were reincarcerated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was determined as follows: one XR-NTX injection provided 4 weeks of treatment. Study patients also had counseling, thus weeks in treatment equaled the weeks of protected time from XR-NTX plus the number of weeks a patient had one or more counseling appointments after the protection from the last XR-NTX dose ended.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), before they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.'}, {'id': 'FG001', 'title': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection\n\nSubjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline (month 1), after they leave the prison. Subjects will also receive one injection 380 mg of extended-release naltrexone at month 2, month 3, and month 4. Subjects will receive weekly psychosocial counseling for six months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Withdr, Transfers-other prisons, dropout', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}]}], 'recruitmentDetails': 'Recruitment started August 2016 and ended June 16, 2018 in the Philadelphia Prison System. Subjects all were recruited while incarcerated.', 'preAssignmentDetails': 'Subjects were stratified to sentenced/not sentenced and male/female'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months\n\nExtended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone after they were released from prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.'}, {'id': 'BG001', 'title': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months\n\nExtended release naltrexone: Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It was administered in this study at the currently marketed dose of 380 mgs. Subjects were randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they left the prison. Both groups received three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects also received weekly psychosocial counseling.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '37.0', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Opioid Drug Use', 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of subjects who used opioids, including heroin, in the past 30 days at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'EuroQol Overall Health', 'classes': [{'title': 'Mobility', 'categories': [{'title': 'No Problems', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Slight Problems', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Moderate Problems', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Severe Problems', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'x=Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Self Care', 'categories': [{'title': 'No Problems', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Slight Problems', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Moderate Problems', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Severe Problems', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'x=Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Doing Usual Activities', 'categories': [{'title': 'No Problems', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': 'Slight Problems', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Moderate Problems', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Severe Problems', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'x=Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Pain or Discomfort', 'categories': [{'title': 'No Problems', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Slight Problems', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Moderate Problems', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Severe Problems', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'x=Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Anxiety and Depression', 'categories': [{'title': 'No Problems', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Slight Problems', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Moderate Problems', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Severe Problems', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'x=Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Mobility measures walking ability. score =0 to 3, with 0= no problem, 1=slight problems, and 2=moderate problems, and 3=severe problems. X=Did not want to answer.', 'unitOfMeasure': 'Participants'}, {'title': 'Beck Depression Index', 'classes': [{'categories': [{'title': 'No Depression', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Clinical Depression', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Timeline Follow-Back', 'classes': [{'title': 'Heroin Use', 'categories': [{'measurements': [{'value': '21.91', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '25.56', 'spread': '9.59', 'groupId': 'BG001'}, {'value': '23.71', 'spread': '11.3', 'groupId': 'BG002'}]}]}, {'title': 'Methadone Use', 'categories': [{'measurements': [{'value': '.92', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '1.19', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '1.05', 'spread': '4.7', 'groupId': 'BG002'}]}]}, {'title': 'Other Opioids', 'categories': [{'measurements': [{'value': '8.46', 'spread': '12.05', 'groupId': 'BG000'}, {'value': '6.97', 'spread': '11.06', 'groupId': 'BG001'}, {'value': '7.73', 'spread': '11.56', 'groupId': 'BG002'}]}]}, {'title': 'Benzodiazepines', 'categories': [{'measurements': [{'value': '6.36', 'spread': '10.59', 'groupId': 'BG000'}, {'value': '7.78', 'spread': '11.11', 'groupId': 'BG001'}, {'value': '7.06', 'spread': '10.84', 'groupId': 'BG002'}]}]}, {'title': 'Cocaine', 'categories': [{'measurements': [{'value': '12.7', 'spread': '13.01', 'groupId': 'BG000'}, {'value': '14.19', 'spread': '13.27', 'groupId': 'BG001'}, {'value': '13.44', 'spread': '13.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean Days of drug use past 30 days before baseline', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Risk Assessment Battery', 'classes': [{'title': 'Drug Risk Score', 'categories': [{'measurements': [{'value': '3.19', 'spread': '4.33', 'groupId': 'BG000'}, {'value': '4.42', 'spread': '4.87', 'groupId': 'BG001'}, {'value': '3.79', 'spread': '4.6', 'groupId': 'BG002'}]}]}, {'title': 'Sex Risk Scoe', 'categories': [{'measurements': [{'value': '5.61', 'spread': '2.89', 'groupId': 'BG000'}, {'value': '5.94', 'spread': '2.66', 'groupId': 'BG001'}, {'value': '5.77', 'spread': '2.77', 'groupId': 'BG002'}]}]}, {'title': 'Total RAB Score', 'categories': [{'measurements': [{'value': '8.80', 'spread': '6.17', 'groupId': 'BG000'}, {'value': '10.36', 'spread': '6.68', 'groupId': 'BG001'}, {'value': '9.57', 'spread': '6.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Seventeen items make-up scores for Drug-Risk and Sex-Risk in the Risk Assessment Battery (RAB). Drug-Risk is scored from 0 to 22. Sex-Risk is scored from 0 to18. Total Score = Total Drug Risk + Total Sex-Risk. The overall "Total Score" is then divided by 40, the highest possible score. Items are not differentially weighted. Higher values reflect greater frequency of risky behavior.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-17', 'size': 1863731, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-24T16:27', 'hasProtocol': True}, {'date': '2019-05-17', 'size': 638321, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-02-25T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2015-11-23', 'resultsFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-01', 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse to Opioid Use in Subjects by Month 3', 'timeFrame': '12 weeks (month 3)', 'description': 'Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.'}], 'secondaryOutcomes': [{'measure': 'Reincarceration', 'timeFrame': '0 to 28 months', 'description': 'percentage of patients who were reincarcerated'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['opioid addiction'], 'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '37231479', 'type': 'DERIVED', 'citation': 'Cadet T, Jalali A, Jeng PJ, Poole S, Woody G, Murphy SM. Determinants of health-related quality of life among individuals with opioid use disorder, recently released from incarceration. Addict Sci Clin Pract. 2023 May 25;18(1):34. doi: 10.1186/s13722-023-00375-0.'}]}, 'descriptionModule': {'briefSummary': 'This study is a collaboration between the University of Pennsylvania, the Philadelphia Prison System, and the North East Treatment Center (NETSteps). It purpose is to study the impact of an injectable opiate addiction medication (extended release naltrexone) given before reentry into the community that might help to improve reconnection to healthcare and other support systems, and possibly help reduce recidivism.', 'detailedDescription': 'The primary objectives for this study is to offer tools to support improve healthcare and related outcomes and reduce the risk of relapse and recidivism for opiate addicted prisoners reentering into the community after release from correctional facilities. In this study the investigators examine a medication-assisted therapy (extended release naltrexone) that is likely to be acceptable to correctional facilities and opioid addicted prisoners and that can improve the outcomes achieved by the usual detoxification/treatment referral approach. The results may be used to facilitate policy changes that involve adding extended release naltrexone to correctional facility formularies for use before reentry, and collaborating with one or more outpatient treatment providers to maintain continuity of care. Two hundred (200) opioid addicted prisoners currently incarcerated in the Philadelphia Prison System, who meet study admission criteria and express an interest in extended release naltrexone treatment, who give informed consent and will be scheduled for release within 14 days of being randomized into the study will be enrolled. These 200 subjects will be stratified by sex (male/females), will be 18 years or older, and are not sentenced).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Opioid dependent with physiological features according to Diagnostic and Statistical Manual of Mental Disorders-5th edition\n* Interested in extended release naltrexone treatment\n* Eligible to have health benefits reinstated\n* Detoxified and able to pass a naloxone challenge (e.g. no withdrawal within 30 minutes after receiving 0.8 mg naloxone I.M. and documented by a score \\<5 on the Clinical Opiate Withdrawal Scale\n* Age 18 or above\n* Not being transferred to serve a longer sentence in a State or Federal prison\n* Provide their address or phone number along with the names and contact information of 3 or more persons likely to know where they can be reached with permission to contact them if unable to be reached in other ways\n* Able to speak and read English and provide informed consent\n* able to correctly answer 9 of 10 study quiz items\n* not pregnant and agree to the use of an acceptable form of birth control\n* can access to NET Steps via car or public or other transportation after reentry\n\nExclusion Criteria:\n\n* Planning to move from the Philadelphia area within the next 6 months\n* Neurological, cardiovascular, renal, hepatic (Alanine aminotransferase, Aspartate aminotransferase or Gamma-glutamyl transpeptidase \\>3 times top limit of normal) or another medical disorder that seriously impairs or makes hazardous ability to participate\n* Active tuberculosis\n* Currently psychotic, homicidal, suicidal\n* Uncontrolled seizure disorder\n* History of allergy to naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or any other components of the diluent\n* Chronic pain for which opioids are needed\n* Sentenced to naltrexone Treatment'}, 'identificationModule': {'nctId': 'NCT02617628', 'acronym': 'OAPXRNTX', 'briefTitle': 'Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Improving Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone (Vivitrol) Before vs. After Reentry', 'orgStudyIdInfo': {'id': 'FC14-1409-21688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Before Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months', 'interventionNames': ['Drug: extended release naltrexone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'After Re-entry', 'description': 'Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months', 'interventionNames': ['Drug: extended release naltrexone']}], 'interventions': [{'name': 'extended release naltrexone', 'type': 'DRUG', 'otherNames': ['Vivitrol'], 'description': 'Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.', 'armGroupLabels': ['After Re-entry', 'Before Re-entry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center on the Studies of Addiction', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'George E Woody, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}