Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT03604159
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2018-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}}}}, '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'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], 'ancestors': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Joshua.Lee@nyulangone.org', 'phone': '646-501-3552', 'title': 'Dr. Joshua Lee', 'organization': 'NYU Langone'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 5, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Stomach flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'intoxication induction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'soreness at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in upper-left arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 Weeks', 'description': 'Retained on any form of community buprenorphine treatment at Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '# of Participants Retained on Their Randomly Assigned Treatment at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Retained on assigned treatment at Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean # of Weeks (0-8) on Any Buprenorphine Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Weeks (0-8) on buprenorphine treatment, mean (SD)', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Urine Samples Opioid-negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'units': 'Urine Tests', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'number of opioid-negative urine samples', 'unitOfMeasure': 'urine samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Urine Tests', 'denomUnitsSelected': 'Urine Tests'}, {'type': 'PRIMARY', 'title': 'the # of Participants Re-incarcerated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Re-incarceration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '.05', 'upperLimit': '0.16'}, {'value': '1.06', 'groupId': 'OG001', 'lowerLimit': '0.88', 'upperLimit': '1.23'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-randomization and pre-release, (0-3 months)', 'description': 'Jail medical clinic visits per day following study medication induciton, mean', 'unitOfMeasure': 'jail clinic visits per day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The # of Participants That Received Their Randomly Assigned Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 Weeks', 'description': 'Received assigned study medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'OG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-3 months (pre-release)', 'description': 'Received assigned study medication prior to release as scheduled', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'FG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.\n\nBuprenorphine Extended Release: XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.'}, {'id': 'BG001', 'title': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.\n\nSublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets): SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '42.3', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-11', 'size': 654291, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-30T10:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2018-07-05', 'resultsFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-13', 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8', 'timeFrame': '8 Weeks', 'description': 'Retained on any form of community buprenorphine treatment at Week 8'}, {'measure': '# of Participants Retained on Their Randomly Assigned Treatment at Week 8', 'timeFrame': '8 weeks', 'description': 'Retained on assigned treatment at Week 8'}, {'measure': 'Mean # of Weeks (0-8) on Any Buprenorphine Treatment', 'timeFrame': '8 weeks', 'description': 'Weeks (0-8) on buprenorphine treatment, mean (SD)'}, {'measure': 'Urine Samples Opioid-negative', 'timeFrame': '8 weeks', 'description': 'number of opioid-negative urine samples'}, {'measure': 'the # of Participants Re-incarcerated', 'timeFrame': '8 weeks', 'description': 'Re-incarceration'}, {'measure': 'The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication', 'timeFrame': 'Post-randomization and pre-release, (0-3 months)', 'description': 'Jail medical clinic visits per day following study medication induciton, mean'}], 'secondaryOutcomes': [{'measure': 'The # of Participants That Received Their Randomly Assigned Study Medication', 'timeFrame': '8 Weeks', 'description': 'Received assigned study medication'}, {'measure': 'The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled', 'timeFrame': '0-3 months (pre-release)', 'description': 'Received assigned study medication prior to release as scheduled'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid dependence', 'Buprenorphine', 'primary care treatment', 'extended-release buprenorphine'], 'conditions': ['Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '35093164', 'type': 'DERIVED', 'citation': 'Cheng A, Badolato R, Segoshi A, McDonald R, Malone M, Vasudevan K, Badiei B, Sugarman A, Macdonald R, Mangat J, Giftos J, Lee JD, Tofighi B. Perceptions and experiences toward extended-release buprenorphine among persons leaving jail with opioid use disorders before and during COVID-19: an in-depth qualitative study. Addict Sci Clin Pract. 2022 Jan 29;17(1):4. doi: 10.1186/s13722-022-00288-4.'}, {'pmid': '34495340', 'type': 'DERIVED', 'citation': 'Lee JD, Malone M, McDonald R, Cheng A, Vasudevan K, Tofighi B, Garment A, Porter B, Goldfeld KS, Matteo M, Mangat J, Katyal M, Giftos J, MacDonald R. Comparison of Treatment Retention of Adults With Opioid Addiction Managed With Extended-Release Buprenorphine vs Daily Sublingual Buprenorphine-Naloxone at Time of Release From Jail. JAMA Netw Open. 2021 Sep 1;4(9):e2123032. doi: 10.1001/jamanetworkopen.2021.23032.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18yo incarcerated in NYC jails with known release dates.\n* DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).\n* Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.\n\nExclusion Criteria:\n\n* Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.\n* Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, \\>99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant\n* No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.'}, 'identificationModule': {'nctId': 'NCT03604159', 'briefTitle': 'XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone', 'orgStudyIdInfo': {'id': '18-00823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Buprenorphine Extended-Release', 'description': 'XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.', 'interventionNames': ['Drug: Buprenorphine Extended Release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual Buprenorphine', 'description': 'SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.', 'interventionNames': ['Drug: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)']}], 'interventions': [{'name': 'Buprenorphine Extended Release', 'type': 'DRUG', 'otherNames': ['SUBLOCADE'], 'description': 'XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.', 'armGroupLabels': ['Buprenorphine Extended-Release']}, {'name': 'Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)', 'type': 'DRUG', 'description': 'SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.', 'armGroupLabels': ['Sublingual Buprenorphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joshua D Lee, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'To achieve aims in the approved proposal.', 'ipdSharing': 'YES', 'description': "Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided).", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York City Health and Hospitals Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}