Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT03368794
Status:
WITHDRAWN
Last Update Posted:
2021-03-16
First Post:
2017-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Naloxone to TReatment Entry in the Emergency Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Practical difficulties in starting active recruitment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment entry', 'timeFrame': 'Two weeks', 'description': 'Entry into formal assessment for evidence-based treatment of opioid use disorder'}], 'secondaryOutcomes': [{'measure': 'Treatment retention', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Retention in opioid maintenance treatment or other relevant evidence-based treatment for the substance-related condition, as measured in treatment records, and including the analysis of predictors of retention'}, {'measure': 'Treatment outcome (urinalysis)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Drug-free status in treatment, as documented from hospital records of drug-free urines'}, {'measure': 'Treatment outcome (hair analysis)', 'timeFrame': '3 months', 'description': 'Drug-free status in treatment, as documented by hair analysis'}, {'measure': 'Treatment outcome (self-report)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Drug-free status in treatment, described through self-report (AUDIT, DUDIT)'}, {'measure': 'Treatment outcome (quality of life)', 'timeFrame': '3, 6, 12, 24 and 36 months', 'description': 'Self-report, EQ-5D (European Quality of life - 5 Dimensions) and visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Dependence', 'Opioid Intoxication', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': "The study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.", 'detailedDescription': 'Randomized controlled trial. Subjects are included if they are being treated by an ambulance in the Malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. Subjects are randomized by ambulance staff to either an active intervention, or a control condition:\n\nIntervention: A telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study.\n\nControl: No telephone alert signal is sent, and the active outreach procedure is not carried out. Ambulance staff hand over written information to the individual about how she/he can apply actively for treatment.\n\nPrimary outcome is entry into formal assessment and treatment of the substance use disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent\n\nExclusion Criteria:\n\n* patients unable to understand study information and to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03368794', 'acronym': 'N-TREE', 'briefTitle': 'Naloxone to TReatment Entry in the Emergency Setting', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Naloxone to TReatment Entry in the Emergency Setting', 'orgStudyIdInfo': {'id': 'N-TREE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Telephone alert signal from ambulance staff to out-patient substance use disorder treatment facility, for active outreach aiming to locate and include the patient in long-term evidence-based treatment for the substance use disorder.', 'interventionNames': ['Behavioral: Active treatment referral of opioid overdose survivors to long-term treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Information-only. Ambulance staff hand over written information to the individual about how to seek treatment for the substance use disorder.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Active treatment referral of opioid overdose survivors to long-term treatment', 'type': 'BEHAVIORAL', 'description': 'Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'otherNames': ['Information-only'], 'description': 'Written information from ambulance staff to the patient about how to seek treatment. Patient is able to contact the research treatment facility through a specific phone number, making it possible to study treatment entry in the information-only control condition.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Malmo', 'country': 'Sweden', 'facility': 'Malmö Addiction Center', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'overallOfficials': [{'name': 'Anders Håkansson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University. Region Skåne.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anders C Håkansson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anders C Håkansson', 'investigatorAffiliation': 'Region Skane'}}}}