Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-12 @ 8:19 PM
Study NCT ID:
NCT02871232
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups', 'timeFrame': 'Review over period from January 2010 to December 2016'}], 'secondaryOutcomes': [{'measure': 'Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group', 'timeFrame': 'Review over period from January 2010 to December 2016'}]}, 'conditionsModule': {'conditions': ['Opioid-related Disorders', 'Opioid Addiction', 'Narcotic Abuse', 'Drug Abuse']}, 'descriptionModule': {'briefSummary': 'To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The Poison Center Program obtains data from the general population of the US, Treatment Center Programs obtain data from those entering treatment for opioid addiction, and the College Survey Program surveys self-identified students attending a 2- or 4- year college, university, or technical school', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny patient with data in the RADARS system\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT02871232', 'briefTitle': 'Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ER/LA Opioid REMS Program Companies (RPC)'}, 'officialTitle': 'Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol', 'orgStudyIdInfo': {'id': 'Assessments 5.2-5.4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intentional exposures among adolescents and adults', 'interventionNames': ['Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion']}, {'label': 'Unintentional exposures among infants and children', 'interventionNames': ['Other: Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion']}], 'interventions': [{'name': 'Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion', 'type': 'OTHER', 'armGroupLabels': ['Intentional exposures among adolescents and adults', 'Unintentional exposures among infants and children']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ER/LA Opioid REMS Program Companies (RPC)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}