Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT05180669
Status:
TERMINATED
Last Update Posted:
2025-06-13
First Post:
2021-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reward-based Technology to Improve OUD Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-24', 'releaseDate': '2025-11-12'}], 'estimatedResultsFirstSubmitDate': '2025-11-12'}}, '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', 'interventionModelDescription': 'Both groups will be enrolled at the same time through, with group designated by randomization, and monitored through the 12-week RCT as well as follow ups at 1-, 3-, and 6-months post enrollment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Enrollment was impacted by a massive epidemiological shift that led to reduced rates of presentation to the ED for opioid overdose. Despite more than a year of adjusting protocols and site expansion, we were not able to increase the enrollment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent outpatient intake scheduled - Phase 2 RCT', 'timeFrame': '1 timepoint - Before patients are discharged from acute care at the time of study enrollment', 'description': 'Percentage of patients who schedule an outpatient Suboxone intake prior to discharge from acute care'}, {'measure': 'Percent outpatient intakes completed - Phase 2 RCT', 'timeFrame': 'Typically, within ~48 hours of discharge from acute care', 'description': 'Percentage of patients who complete their outpatient Suboxone intake'}, {'measure': 'Sustained abstinence - Phase 2 RCT (Month 1)', 'timeFrame': "1 month from participant's enrollment", 'description': 'Proportion of participants with sustained abstinence (composite of biochemical \\& self-report data) from opioids'}, {'measure': 'Sustained abstinence - Phase 2 RCT (Month 3)', 'timeFrame': "3 months from participant's enrollment", 'description': 'Proportion of participants with sustained abstinence (composite of biochemical \\& self-report data) from opioids'}, {'measure': 'Sustained abstinence - Phase 2 RCT (Month 6)', 'timeFrame': "6 months from participant's enrollment", 'description': 'Proportion of participants with sustained abstinence (composite of biochemical \\& self-report data) from opioids'}, {'measure': 'Longest duration of abstinence - Phase 2 RCT (Month 1)', 'timeFrame': "1 month from participant's enrollment", 'description': 'Longest duration of consecutive days of abstinence (composite of biochemical \\& self-report data)'}, {'measure': 'Longest duration of abstinence - Phase 2 RCT (Month 3)', 'timeFrame': "3 months from participant's enrollment", 'description': 'Longest duration of consecutive days of abstinence (composite of biochemical \\& self-report data)'}, {'measure': 'Longest duration of abstinence - Phase 2 RCT (Month 6)', 'timeFrame': "6 months from participant's enrollment", 'description': 'Longest duration of consecutive days of abstinence (composite of biochemical \\& self-report data)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Substance Use Disorder', 'Opioid Use Disorder', 'Contingency Management', 'Medication for opioid use disorder', 'Medication-assisted treatment'], 'conditions': ['Opioid Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://q2i.com/oars-cm/', 'label': 'Webpage for OARSCM solution'}]}, 'descriptionModule': {'briefSummary': 'Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This project will utilize a digital mobile platform, Opioid Addiction Recovery Support with contingency management (OARSCM), to increase MAT treatment initiation and adherence among OUD patients recruited from emergency departments and inpatient acute care.', 'detailedDescription': 'Millions of people in the US misuse opioids each year, leading to thousands of deaths and costing billions of dollars in total economic burden. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common and associated with poor outcomes. This STTR Fast Track proposal is designed to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care. To accomplish these aims, the project will enhance the Opioid Addiction Recovery Support (OARS), an existing Q2i company technology, with a new evidence-based reward, contingency management (CM) function. CM interventions systematically reward (reinforce) specific behaviors like treatment initiation and adherence with therapy attendance and drug-free urine tests and are highly efficacious. An OARS solution enhanced with a CM component (OARSCM) that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of treatment behaviors may be key to improving Suboxone initiation and adherence. In Phase 1 of this proposal, the existing OARS clinician portal and patient mobile application will be modified to accommodate entry into the software system from an acute care setting and to automatically manage and deliver rewards to create OARSCM using patient-centered design principles. Focus groups with OUD patients and other key stakeholders will inform design. Primary usability outcomes will be examined, and the program iteratively updated. After meeting milestones, there was a proof-of-concept pilot of usability, acceptability, and effects on initial behavior targets with approximately 20 patients and at least 4 providers. After meeting milestones, this RCT will follow, in which acute care OUD patients appropriate for outpatient Suboxone (N = 102) are recruited and allocated to one of two study conditions: 1) treatment as usual (TAU) with MyMAT, comprised of screening, brief intervention, referral to treatment by a trained clinician, and an educational mobile app (MyMAT), 2) OARSCM. The active intervention window for the two intervention groups will be 12 weeks. Patients will be onboarded prior to discharge from acute care. In the outpatient Suboxone setting, data on treatment adherence and opioid use will be captured from clinical records for six months. Telephone follow-up assessments and vital statics registry reviews will be at month 1, month 3 (end-of-study intervention period), and month 6. Primary Suboxone treatment initiation outcomes will be completing the Suboxone intake. Primary Suboxone treatment outcomes will be sustained abstinence at Month 6 and longest duration of abstinence. Analysis will examine data on cost avoidance and cost savings through reduced acute care visits between study conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\>= 18 years old\n2. Presenting for acute care at UMass University and Memorial hospitals, including EDs, inpatient medical units, or inpatient behavioral health units for opioid addiction related health complaints, including opioid overdose, opioid related medical consequences, opioid intoxication or withdrawal syndromes, and/or seeking help for OUD\n3. Presence of a current DSM-V opioid use disorder (OUD), mild to severe\n4. Medically appropriate for outpatient Suboxone treatment, as judged by the treating clinician and behavioral health consultant or toxicologist working with the patient clinically\n\nExclusion Criteria:\n\n1. Persistent altered mental status (not alert, not oriented, psychotic).\n2. Not interested or willing to participate in Suboxone treatment\n3. Best referral site is NOT one of the study's partner clinics in the central MA region, which will be outpatient MAT clinics and primary care within the UMass system and the three other primary facilities outside of the UMass system.\n4. Unwilling to use the OARSCM app (if assigned)\n5. Does not have access to their own smartphone with at least iOS 7.1 or Android 4.2, the minimal technology required to run the app, or not willing to access clinic-dedicated computer to access the program\n6. Currently in state custody or pending legal action that might lead to imprisonment\n7. Cannot paraphrase the study requirements\n8. Does not read or speak English\n9. Does not reside in the central MA region\n10. Already enrolled into the trial"}, 'identificationModule': {'nctId': 'NCT05180669', 'acronym': 'OARSCM', 'briefTitle': 'Reward-based Technology to Improve OUD Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Q2i, LLC'}, 'officialTitle': 'Reward-based Technology to Improve Opioid Use Disorder Treatment Initiation After an ED Visit - Phase 2', 'orgStudyIdInfo': {'id': 'H00017879-2'}, 'secondaryIdInfos': [{'id': 'R42DA049448', 'link': 'https://reporter.nih.gov/quickSearch/R42DA049448', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OARSCM', 'description': 'OARSCM (n = 51) patients will receive the same TAU procedures described above. They will also earn chances for prizes, with the same targeted behaviors, escalation of chances for prizes for each targeted behavior in a row, and reset criteria described. Briefly, for scheduling a MOUD treatment intake, patients will earn 2 chances for prizes. Chances for prizes will increase by 2 chances with documentation of each targeted behavior in a row up to a maximum of 10 draws/targeted behavior. With 38 targeted behaviors (schedule MOUD intake, complete intake, 12 opioid-negative urine toxicology/week over 12 weeks plus bonuses for cocaine-negative tests, and 12 group/individual therapy/week over 12 weeks), patients can earn up to 252 chances for prizes during the 12-week RCT.', 'interventionNames': ['Other: OARSCM Software Application']}, {'type': 'SHAM_COMPARATOR', 'label': 'TAU with MyMAT', 'description': 'TAU (n = 51) In the acute care setting, the Behavioral Health Service provides SBIRT for substance use disorders, including OUD. They provide SBIRT as part of TAU, including a warm handoff to an outpatient MOUD treatment with a scheduled outpatient appointment, optimally within 48 hours of the ED visit. TAU outpatient suboxone treatment consists of urine toxicology screening, group/individual therapy, and MOUD prescription continent on drug-negative urine toxicology. Treatment visits are typically weekly in weeks 1-4 and then taper over time, to every other week in weeks 5-8, and monthly in weeks 9-12 and after. Nonadherence can lead to increased frequency/intensity of therapy and urine toxicology until the patient stabilizes. If increased frequency/intensity is unsuccessful, patients may be referred to detoxification and subsequently re-admitted to outpatient care when appropriate. Patients will receive MyMAT a mobile application with educational content regarding MOUD treatment.', 'interventionNames': ['Other: MyMAT Software Application']}], 'interventions': [{'name': 'OARSCM Software Application', 'type': 'OTHER', 'otherNames': ['Opioid Addiction Recovery Support - Contingency Management (OARSCM)'], 'description': 'Access is granted to participants for 12 weeks to the OARSCM platform which includes reinforcements for meeting MOUD treatment goals.', 'armGroupLabels': ['OARSCM']}, {'name': 'MyMAT Software Application', 'type': 'OTHER', 'otherNames': ['MyMAT'], 'description': 'Access is granted to the MyMAT mobile application for 12 weeks which provides educational content regarding MOUD treatment.', 'armGroupLabels': ['TAU with MyMAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Chan Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'overallOfficials': [{'name': 'Rachel Davis-Martin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Massachusetts Chan Medical School'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Data will be available starting 6 months after publication of results.', 'ipdSharing': 'YES', 'description': 'We plan to share all individual participant data (IPD) that underlie published results.', 'accessCriteria': 'Deidentified data will be accessible to researchers who wish to conduct analyses not reported in prior publications. The study principal investigator will review any request for data to ensure no overlapping analyses. Deidentified data will be shared via secure, HIPAA-compliant data transfers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Q2i, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-12', 'type': 'RELEASE'}, {'date': '2025-11-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Q2i, LLC'}}}}