Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 6:52 AM
Study NCT ID:
NCT03190356
Status:
TERMINATED
Last Update Posted:
2018-05-15
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soberlink - MAP Outcomes Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-06-14', 'lastUpdatePostDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recidivism', 'timeFrame': '90 days duration of subject participation', 'description': 'Determination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Alcohol Addiction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cancer.org/cancer/cancer-causes/diet-physical-activity/alcohol-use-and-cancer.html', 'label': 'American Cancer Society - Alcohol Use and Cancer'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.", 'detailedDescription': "The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "30 adult male/female clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject between ages of 21-65 years old\n* Subject is active in MAP's program with recovery support services\n* Subject has received acute professional treatment in the last 120 days\n* Primary or secondary diagnosis is Alcohol Use Disorder\n* Subject willing to use Soberlink Device to provide BAC\n* Subject is willing to discuss Soberlink test results with case manager\n* Subject is willing to sign a Soberlink Client Agreement\n* Subject is English speaking and reading\n\nExclusion Criteria:\n\n* Alcohol Use Disorder is not a primary or secondary diagnosis\n* Subject is currently taking anti-alcohol medications\n* Subject will not be in the United States through duration of study\n* Subject is unwilling to properly use the device\n* Subject is non-English speaking and reading\n* Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder, such as schizophrenia"}, 'identificationModule': {'nctId': 'NCT03190356', 'briefTitle': 'Soberlink - MAP Outcomes Study Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soberlink Healthcare LLC'}, 'officialTitle': 'Soberlink - MAP Outcomes Study Protocol', 'orgStudyIdInfo': {'id': 'SLMAPPROT-2017-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary diagnosis alcohol use disorder (AUD)', 'description': "Primary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System", 'interventionNames': ['Device: Soberlink Cellular Device']}, {'label': 'Secondary diagnosis alcohol use disorder (AUD)', 'description': "Secondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System", 'interventionNames': ['Device: Soberlink Cellular Device']}], 'interventions': [{'name': 'Soberlink Cellular Device', 'type': 'DEVICE', 'otherNames': ['MAP patient engagement platform (EHR)'], 'description': 'Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses.', 'armGroupLabels': ['Primary diagnosis alcohol use disorder (AUD)', 'Secondary diagnosis alcohol use disorder (AUD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78746', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'MAP Health Management LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Shannon Hanrahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shannon Hanrahan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soberlink Healthcare LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MAP Health Management LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}