Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-17 @ 2:36 AM
Study NCT ID:
NCT02120612
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2014-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], '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': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opiate Overdose Knowledge Scale (OOKS)', 'timeFrame': '0-3 months', 'description': 'The Opiate Overdose Knowledge Scale (OOKS) is an empirically-validated scale that measures knowledge of: (1) the risks, warning signs, and life-saving steps to take regarding an opioid overdose; and, (2) the appropriate use of naloxone.'}], 'secondaryOutcomes': [{'measure': 'History Survey', 'timeFrame': '0-3 months', 'description': "The History Survey assesses subjects' experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone)."}, {'measure': 'Guilt and Shame Proneness Scale (GASP)', 'timeFrame': '0-3 months', 'description': 'The Guilt and Shame Proneness Scale (GASP) is an empirically-validated measure to assess subject shame and guilt and behavioral response patterns.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid Dependence', 'Addiction', 'Naloxone', 'Naloxone Education', 'Opiate Overdose Knowledge Scale', 'OOKS'], 'conditions': ['Opioid Dependence', 'Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect that an educational intervention has on patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a suburban outpatient treatment program.', 'detailedDescription': 'The outpatient Addiction Services program at Linden Oaks will begin implementing an educational program on the signs of opioid overdose and naloxone for all patients who have a diagnosis of opiate dependence in the investigators suburban treatment program. Subjects will be recruited from that population and administered a new, empirically validated scale (i.e. the Opiate Overdose Knowledge Scale; OOKS) both pre- and post-intervention to measure the effect that the educational program has on patient knowledge.\n\nPatients will also be surveyed (i.e. History Survey) about their experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone) prior to treatment; and, this History Survey will then be re-administered by phone, 1-3 months after discharge. The aim is to measure whether education influences patient behavior. Finally, all subjects will be administered an empirically-validated measure to assess subject shame and guilt (i.e. Guilt and Shame Proneness Scale; GASP), and response patterns in their behavior, to evaluate whether shame and guilt predict behavior at follow-up. The investigators will compare to data (i.e. OOKS, GASP, and History Survey) from a historical control group prior to the implementation of the educational program - and, also at 1-3 month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects who have been diagnosed with a DSM opioid use disorder enrolled in an outpatient treatment program for the substance use disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects who have been diagnosed with a DSM opioid use disorder by LOH staff.\n\nExclusion Criteria:\n\n* Subjects who are deemed to have moderate to severe cognitive impairment - as assessed by standard psychiatric evaluation from Linden Oaks clinical staff - will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02120612', 'briefTitle': 'Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program', 'organization': {'class': 'OTHER', 'fullName': 'Edward-Elmhurst Health System'}, 'officialTitle': 'Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program', 'orgStudyIdInfo': {'id': 'LOH32414'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Historical Control Group', 'description': 'Historical Control Group will be assessed for knowledge prior to the implementation of the educational program.'}, {'label': 'Naloxone Education Intervention Group', 'description': 'Group to begin receiving the Naloxone Education Intervention on the signs of opioid overdose and appropriate use of naloxone.', 'interventionNames': ['Other: Naloxone Education Intervention']}], 'interventions': [{'name': 'Naloxone Education Intervention', 'type': 'OTHER', 'description': 'The Naloxone Education Intervention is a curriculum that has been adapted from New York State Department of Health\'s, "Opioid Overdose Prevention" program for non-medical responders.', 'armGroupLabels': ['Naloxone Education Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Linden Oaks', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'David C Lott, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linden Oaks Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}