Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT05412966
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Abstinence From Illicit Opioids', 'timeFrame': 'From Baseline to Week4', 'description': 'Abstinence from illicit opioid use as measured by urine immunoassay to detect the presence/absence of opioids.'}, {'measure': 'Treatment Retention', 'timeFrame': 'From Baseline to Week 4', 'description': 'Treatment retention measured as time to drop out (last face to face contact with a patient) and analyzed using the Kaplan Meier method'}, {'measure': 'Device Wearing Time', 'timeFrame': 'From Baseline to Week 4', 'description': 'Device wearing time as measured by EmbracePlus wearable device data'}, {'measure': 'Physiological Biomarker Data', 'timeFrame': 'From Baseline to Week 4', 'description': 'Physiological data (e.g., heart rate) as measured by EmbracePlus wearable device'}], 'primaryOutcomes': [{'measure': 'PEAR-002B User Satisfaction Surveys', 'timeFrame': 'Week 1', 'description': 'Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints'}, {'measure': 'PEAR-002B Qualitative User Experience Interviews', 'timeFrame': 'Week 1', 'description': 'Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes'}, {'measure': 'Buprenorphine Initiation Success', 'timeFrame': 'Week 1', 'description': 'Buprenorphine initiation success will be measured as the proportion of participants attending the post-buprenorphine initiation visit'}, {'measure': 'Medication Adherence Rates', 'timeFrame': 'From Week 1 to Week 4', 'description': 'Buprenorphine adherence rates as measured by proportion of total urine samples testing positive for buprenorphine or norbuprenorphine'}], 'secondaryOutcomes': [{'measure': 'PEAR-002B Engagement Data', 'timeFrame': 'From Baseline to Week 1', 'description': 'PEAR-002B engagement rates as measured by participant use patterns data'}, {'measure': 'reSET-O Qualitative User Experience Interviews', 'timeFrame': 'Week 4', 'description': 'Qualitative user experience interviews will be coded and analyzed using grounded theory methodology to identify common themes'}, {'measure': 'reSET-O User Satisfaction Surveys', 'timeFrame': 'Week 4', 'description': 'Satisfaction survey questions will be rated on a 5-point Likert scale ranging from "not at all satisfied" to "very satisfied". Descriptive statistics will be calculated for quantitative and ordinal endpoints'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['digital therapeutic'], 'conditions': ['Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '36662568', 'type': 'DERIVED', 'citation': 'Luderer H, Enman N, Gerwien R, Braun S, McStocker S, Xiong X, Koebele C, Cannon C, Glass J, Maricich Y. A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2023 Jan 20;12:e43122. doi: 10.2196/43122.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.', 'detailedDescription': 'The purpose of this study is to develop and evaluate the acceptability of a novel feature for use with the prescription digital therapeutic reSET-O.\n\nThis feature aims to improve the quality of treatment for opioid use disorder (OUD) patients starting buprenorphine initiation at home by providing new digital content and withdrawal symptom assessment to support them during this process.\n\nThis study will evaluate the acceptability of this new feature and assess success of at-home buprenorphine initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent prior to any study specific assessments being performed\n2. Male or female ≥18 years of age, inclusive\n3. English proficiency to meaningfully participate in consent process, assessment and intervention\n4. Meets clinical sites criteria for buprenorphine initiation (e.g. current opioid use)\n5. Currently receiving buprenorphine outpatient treatment for OUD (Part 1) or wishing to start buprenorphine treatment\n6. Capable of using common software applications on an internet-enabled mobile device (smart phone or tablet)\n7. Interested in testing or using PEAR-002b\n8. No prior history of reSET-O use\n9. Has not participated in any other investigational drug trials within the past 30 days (or within 5 half-lives of study drug, whichever is longer) of enrollment\n10. Is considered appropriate for participation by their clinician\n\nExclusion Criteria:\n\n1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of OUD and on methadone or naltrexone pharmacotherapy\n2. DSM-5 diagnosis of OUD and already on buprenorphine\n3. Planning to move out of the geographic area within 2 months\n4. Unable to use English to participate in the consent process, the interventions, or assessments\n5. Inability to comply with study procedures, due to severe medical conditions or otherwise\n6. Currently receiving inpatient treatment for OUD\n7. Women who are pregnant'}, 'identificationModule': {'nctId': 'NCT05412966', 'briefTitle': 'Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pear Therapeutics, Inc.'}, 'officialTitle': 'A Feasibility Study of PEAR-002b, a Novel Prescription Digital Therapeutic to Support Unobserved Buprenorphine Initiation and Adherence in Opioid Use Disorder Outpatients', 'orgStudyIdInfo': {'id': 'PEAR-002-101'}, 'secondaryIdInfos': [{'id': 'R44DA049493', 'link': 'https://reporter.nih.gov/quickSearch/R44DA049493', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEAR-002B / reSET-O', 'description': 'Digital Therapeutic', 'interventionNames': ['Device: PEAR-002B', 'Device: reSET-O']}], 'interventions': [{'name': 'PEAR-002B', 'type': 'DEVICE', 'description': 'PEAR-002B is a novel prescription digital therapeutic to support unobserved buprenorphine initiation and adherence in Opioid Use Disorder', 'armGroupLabels': ['PEAR-002B / reSET-O']}, {'name': 'reSET-O', 'type': 'DEVICE', 'description': 'reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.', 'armGroupLabels': ['PEAR-002B / reSET-O']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute, LLC', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}], 'overallOfficials': [{'name': 'Michael Hassman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hassman Research Institute, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pear Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kaiser Foundation Research Institute', 'class': 'OTHER'}, {'name': 'Whitman-Walker Institute, Inc.', 'class': 'OTHER_GOV'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Hassman Research Institute, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}