Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT05339256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-31
First Post:
2022-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual
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': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, active-control, open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2022-04-14', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to drop out', 'timeFrame': '12 weeks', 'description': 'Comparing time to drop out between the treatment arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).', 'detailedDescription': 'The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet DSM-5 criteria for OUD\n* Voluntarily seeking buprenorphine treatment for OUD\n* Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification\n* Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder\n* Concurrent methadone, buprenorphine, or vivitrol maintenance treatment\n* Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)\n* Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients\n* Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation\n* Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide\n* Legally mandated to substance use disorder treatment.'}, 'identificationModule': {'nctId': 'NCT05339256', 'briefTitle': 'Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder', 'orgStudyIdInfo': {'id': '8305'}, 'secondaryIdInfos': [{'id': 'R21DA055835', 'link': 'https://reporter.nih.gov/quickSearch/R21DA055835', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telehealth buprenorphine induction and maintenance', 'description': 'Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine', 'interventionNames': ['Drug: Buprenorphine SL', 'Other: Telehealth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard in-person SL buprenorphine induction and maintenance', 'description': 'In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.', 'interventionNames': ['Drug: Buprenorphine SL', 'Other: In-person treatment as usual']}], 'interventions': [{'name': 'Buprenorphine SL', 'type': 'DRUG', 'description': 'Up to 24 mg per day', 'armGroupLabels': ['Standard in-person SL buprenorphine induction and maintenance', 'Telehealth buprenorphine induction and maintenance']}, {'name': 'Telehealth', 'type': 'OTHER', 'description': 'Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session', 'armGroupLabels': ['Telehealth buprenorphine induction and maintenance']}, {'name': 'In-person treatment as usual', 'type': 'OTHER', 'description': 'in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.', 'armGroupLabels': ['Standard in-person SL buprenorphine induction and maintenance']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Christina Brezing, MD', 'role': 'CONTACT', 'email': 'cb3108@columbia.edu', 'phone': '646-774-6132'}, {'name': 'Elizabeth Martinez', 'role': 'CONTACT', 'phone': '646-774-8181'}], 'overallOfficials': [{'name': 'Christina Brezing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'beginning twelve months and ending 5 years after article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)', 'accessCriteria': 'to researcher who provides a methodologically sound proposal to achieve aims in approved proposal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Christina Ann Brezing', 'investigatorAffiliation': 'New York State Psychiatric Institute'}}}}