Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 8:00 AM
Study NCT ID:
NCT04822168
Status:
WITHDRAWN
Last Update Posted:
2021-12-07
First Post:
2020-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement in B/N Treatment -RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-20', 'size': 180561, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-14T13:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was not implemented due to. change in study site and scope.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Opioid Overdoses (Total of non-fatal self-report, clinic-reported, and fatal)', 'timeFrame': '24 weeks', 'description': 'To examine the effect of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N treatment on the number of self-reported (with and without naloxone administered), county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study follow-up.'}, {'measure': 'Self-Reported Opioid Use', 'timeFrame': '24 Weeks', 'description': 'To examine the differences in self-reported illicit opioid use between MySafeRx Inspire Flex information alone + ACTS Standard Care B/N treatment.'}, {'measure': 'Outpatient Buprenorphine Treatment Retention', 'timeFrame': '24 Weeks', 'description': 'To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on retention in B/N treatment based on active B/N prescription at 12 and 24-week period.'}, {'measure': 'Mental Health Symptomatology', 'timeFrame': '24 weeks', 'description': 'To examine the differences in mental health symptomatology using the BSI between MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment during the 24-week study period.'}], 'primaryOutcomes': [{'measure': 'Effect of Remote Motivational Enhancement (RME) Sessions on Early Engagement in B/N Treatment', 'timeFrame': '5 weeks', 'description': 'To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.'}], 'secondaryOutcomes': [{'measure': 'Proportion of days engaged in dosing of B/N during first 2 weeks.', 'timeFrame': '2 weeks post discharge', 'description': 'To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment on early engagement in B/N treatment based on the proportion of participants a) who receive at least one outpatient B/N dose in first 7 days and b) who receive at least one outpatient B/N prescription at ACTS in the first 14 days post discharge from detox.'}, {'measure': 'Opioid-Related Deaths', 'timeFrame': '24 weeks', 'description': 'To examine the effects of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N on number of opioid-related deaths (as measured by county coroner report and clinic report) during the 6-months after discharge from inpatient detox.'}, {'measure': 'Illicit Opioid Use Measured by Urine Toxicology Screening', 'timeFrame': '24 weeks', 'description': 'To examine the differences in opioid use as measured by monthly urine toxicology for illicit opioids between MySafeRx Inspire Flex and information alone + ACTS Standard Care B/N treatment during a 24-week study period.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder']}, 'referencesModule': {'references': [{'pmid': '30249279', 'type': 'BACKGROUND', 'citation': 'Schuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.'}]}, 'descriptionModule': {'briefSummary': 'Opioid overdoses are a significant problem nationwide and novel interventions that can prevent overdose by improving Buprenorphine/ Naloxone (B/N) treatment for opioid use disorder are a public health priority. This study will both investigate the effects of starting remote motivational enhancement during inpatient detoxification on rates of engagement in B/N treatment and evaluate the impact of MySafeRx, a mobile device application which integrates remote motivational coaching with daily observed dosing from secure electronic pill dispensers at home via videoconference, on treatment retention and overdose prevention. Broad dissemination of this new intervention could help communities across the nation expand and advance their capacity to increase B/N treatment engagement and retention, enhance medication adherence, and prevent overdose.', 'detailedDescription': 'The objective of this study is to conduct a randomized controlled trial (RCT) to evaluate an innovative strategy among opioid use disorder patients being discharged from detox. This study will evaluate the extent to which remote motivational enhancement sessions via videoconference and the option for flexible daily dosing at home with MySafeRx can improve engagement and retention with B/N treatment after detox in a county where access to outpatient, take-home B/N prescriptions are more limited compared to in-person daily B/N dosing and treatment. This study seeks to expand our understanding about what works to prevent opioid overdose by incorporating a RCT evaluating the effects of remote motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox facility and during early treatment in order to increase treatment engagement with daily outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to access the MySafeRx app and complete their daily motivational interview sessions. This study will generate new knowledge about the most effective way to prevent overdose and engage patients in B/N treatment with observed daily dosing.\n\nThe primary aim of this study is:\n\nEngagement: To examine the effect of Remote Motivational Enhancement (RME) sessions + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on early engagement in outpatient B/N treatment based on the number of daily doses of prescribed B/N during the first 5 weeks post-detox.\n\nHypothesis: Participants enrolled in RME + MySafeRx Inspire Flex arm will be engaged in outpatient B/N treatment with significantly higher number of daily doses of prescribed B/N during the first 5 weeks post-detox than the information alone arm.\n\nSecondary Aims:\n\nEarly Engagement: To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment on early engagement in B/N treatment based on the proportion of participants a) who receive at least one outpatient B/N dose in first 7 days and b) who receive at least one outpatient B/N prescription at ACTS in the first 14 days post discharge from detox.\n\nOpioid-Related Deaths: To examine the effects of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N on number of opioid-related deaths (as measured by county coroner report and clinic report) during the 6-months after discharge from inpatient detox.\n\nOpioid Use (toxicology): To examine the differences in opioid use as measured by monthly urine toxicology for illicit opioids between MySafeRx Inspire Flex and information alone + ACTS Standard Care B/N treatment during a 24-week study period.\n\nOther Pre-Specified Outcomes:\n\nOverdoses: To examine the effect of RME + MySafeRx Inspire Flex versus information + ACTS Standard Care B/N treatment on the number of self-reported (with and without naloxone administered), county coroner reported, and clinic-reported opioid overdoses, throughout the 24 weeks of the study follow-up.\n\nOpioid Use (self-report): To examine the differences in self-reported illicit opioid use between MySafeRx Inspire Flex information alone + ACTS Standard Care B/N treatment.\n\nTreatment Retention: To examine the effect of RME + MySafeRx Inspire Flex versus information alone + ACTS Standard Care on retention in B/N treatment based on active B/N prescription at 12 and 24-week period.\n\nMental Health Symptoms: To examine the differences in mental health symptomatology using the BSI between MySafeRx Inspire Flex versus information alone + ACTS Standard Care B/N treatment during the 24-week study period.\n\nFor the current proposal, the investigators plan to recruit up to 120 B/N eligible patients during the high-risk period of transition out of detox into outpatient B/N treatment in order to be able to randomize 104 participants. Study participants will be recruited from the outpatient detox program at ACTS in Tampa, Florida. The investigators aim to recruit 2 patients a week for the study and randomize, on average, one patient to the MySafeRx program each week. Study participants will participate in a baseline assessment and six follow-up assessments at week 4, week 8, week 12, week 16, week 20, and week 24. These assessments will be conducted by the project coordinator and will occur via phone or at the ACTS facility (baseline assessment will always occur at ACTS detox prior to discharge). To protect the privacy of this information, the assessments will be identified only by a code number linked to study participants with a key that is only accessible to the data analyst. Study assessments will take approximately one and a half hours to complete.\n\nOnce the participant has consented, completed the baseline assessment, and a PI or Co-I has approved them to participate, they will be randomized to either MySafeRx or Standard Care. Given the study population, the investigators assume there will be some loss of participants at follow-up. The investigators have planned for this in the assessment of appropriate sample size, as well as in the data analysis procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 65 years\n* opioid use disorder\n* stepping down from inpatient detox services\n* willing to engage in daily outpatient supervised dosing of B/N.\n\nExclusion Criteria:\n\n* cognitively impaired (Unable to complete consent quiz at 90% accuracy AND MOCA \\< 25/30 relative exclusion requiring PI approval, absolute exclusion for MOCA\\<21/30) (Nasreddine,et al., 2005)\n* homeless without any expressed interest in attaining housing after detox discharge\n* reporting active homicidal or suicidal ideation with an imminent plan\n* current mania or psychosis\n* expected incarceration in next 3 months (those that are incarcerated during the study will be removed from the study)\n* unable or unwilling to use a mobile device\n* medical contraindication to B/N\n* unable to complete baseline assessments\n* unstable medical illness who expect hospitalization in the next 3 months\n* pregnant women (if a patient becomes pregnant while participating in this study, they will be withdrawn)\n* prisoners\n* court-ordered individuals\n* is non-English speaking'}, 'identificationModule': {'nctId': 'NCT04822168', 'acronym': 'MySafeRx', 'briefTitle': 'Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement in B/N Treatment -RCT', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Effects of Remote Motivational Enhancement & MySafeRx on Post-Detox Engagement and Retention in B/N Treatment (MySafeRx) - RCT', 'orgStudyIdInfo': {'id': 'PRO00038163 - RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Standard Care through detox-based opioid treatment with B/N and weekly urine toxicology screening', 'interventionNames': ['Other: Standard Care']}, {'type': 'EXPERIMENTAL', 'label': 'MySafeRx™ Intervention', 'description': 'The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of B/N medication within a secure medication storage device, and a standardized protocol for supervising self-administration of medication via videoconferencing.', 'interventionNames': ['Other: MySafeRx™']}], 'interventions': [{'name': 'MySafeRx™', 'type': 'OTHER', 'description': 'The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.', 'armGroupLabels': ['MySafeRx™ Intervention']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Standard Care through office-based opioid treatment with B/N dosing, on-site counseling and regular urine toxicology screening', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33610', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ACTS Adult Addiction Receiving Facility (AARF)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Kathleen Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Florida'}, {'name': 'Zev Schuman-Olivier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge Health Alliance'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publication and within 12 months of completion of the analysis of study primary aims, anonymous and de-identified data will be made available at the Open Science Framework (http://osf.io/) and/or Harvard Dataverse (https://dataverse.harvard.edu/) so that other investigators can verify or follow-up on the reported analyses.', 'ipdSharing': 'YES', 'description': 'De-identified data related to our outcome measures will be included in the IPD sharing plan, in addition to our study protocol, informed consent, and analytic plan.', 'accessCriteria': 'Anonymous and de-identified data will be stored on the Open Science Framework website (http://osf.io/) and/or Harvard Dataverse to be made available to other researchers to verify the research results. Before publication, only USF and CHA investigators will have direct access to the data, and only the CHA HERLab investigators will have access to the analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cambridge Health Alliance', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}