Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05481112
Status:
WITHDRAWN
Last Update Posted:
2024-02-29
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Optimal XR-Buprenorphine Initiation Points in Jail
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': 'C000627685', 'term': 'Sublocade'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study was not initiated due to policy changes in Massachusetts (the proposed study sites).', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release', 'timeFrame': 'Up to Month 6', 'description': 'Data derived from clinic records.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period', 'timeFrame': 'Up to Month 6', 'description': 'Includes initiation of MOUD other than XR-B.'}, {'measure': 'Number of Days of Opioid Use at 1 Month Post-Release', 'timeFrame': '1 Month Post-Release (Up to Month 7)', 'description': 'Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks participants to estimate number of days of drug use over the previous month.'}, {'measure': 'Number of Days of Opioid Use at 3 Months Post-Release', 'timeFrame': '3 Months Post-Release (Up to Month 10)', 'description': 'Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks patients to estimate number of days of drug use over the previous month.'}, {'measure': 'Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period', 'timeFrame': 'Up to Month 6', 'description': 'Participants indicate their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving. The questionnaire is administered at baseline and then monthly over the incarceration phase.'}, {'measure': 'Mean K-6 Distress Scale Score during Incarceration Period', 'timeFrame': 'Up to Month 6', 'description': 'K-6 Distress Scale is a 6-item self-report measure of psychological distress. Participants rank each item on a 5-point Likert scale ranging from 0 (None of the time) to 4 (All of the time). The total score is the sum of responses and ranges from 0 to 24; higher scores indicate higher levels of psychological distress. The questionnaire is administered at baseline and then monthly over the incarceration phase.'}, {'measure': 'Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release', 'timeFrame': '1 Month Post-Release (Up to Month 7)', 'description': 'Data derived from clinic records.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['XR-Buprenorphine', 'Sublocade', 'Medication for Opioid Use Disorder (MOUD)'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Incarcerated adults able to provide written informed consent in English.\n2. Currently sentenced with pending release date between 3-7 months.\n3. Current moderate-to-severe opioid use disorder (DSM-5)\n4. Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)\n5. Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.\n\nExclusion Criteria:\n\n1. Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate\n2. Pregnancy, planning conception, or breast-feeding\n3. Allergy, hypersensitivity or medical contraindication to either medication\n4. Chronic pain requiring opioid pain management\n5. On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.'}, 'identificationModule': {'nctId': 'NCT05481112', 'briefTitle': 'Assessing Optimal XR-Buprenorphine Initiation Points in Jail', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Assessing Optimal XR-Buprenorphine Initiation Points in Jail', 'orgStudyIdInfo': {'id': '22-00326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XR-B Induction at Admission', 'description': 'Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release.\n\nDosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.', 'interventionNames': ['Drug: Extended-Release Buprenorphine Injection']}, {'type': 'EXPERIMENTAL', 'label': 'XR-B Induction at Pre-Release', 'description': 'Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release.\n\nDosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.', 'interventionNames': ['Drug: Extended-Release Buprenorphine Injection']}], 'interventions': [{'name': 'Extended-Release Buprenorphine Injection', 'type': 'DRUG', 'otherNames': ['Sublocade'], 'description': 'Extended-release buprenorphine (XR-B, Sublocade) is manufactured by Indivior. XR-B consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades.', 'armGroupLabels': ['XR-B Induction at Admission', 'XR-B Induction at Pre-Release']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Farabee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David Farabee; david.farabee@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.', 'accessCriteria': 'The investigator who proposed to use the data will have access to data upon reasonable request. Requests should be directed to david.farabee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}