Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-01-11 @ 8:30 AM
Study NCT ID:
NCT05860959
Status:
COMPLETED
Last Update Posted:
2025-10-16
First Post:
2023-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUBLOCADE Long-term Outcomes
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants achieving DSM-5 remission, early or sustained, (yes/no) while on initial SUBLOCADE treatment by 6 months and 1, 1.5, 2, 2.5, and 3 years from study Baseline', 'timeFrame': 'up to a maximum of 4 years', 'description': '* Definition of early remission: None of the criteria for OUD has been met for at least 3 months but for less than 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met.\n* Definition of sustained remission: None of the criteria for OUD has been met for at least 12 months with the exception that Criterion 4 ("Craving, or a strong desire or urge to use opioids,") may be met.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary: Participants with "no symptoms" or improving by ≥1 DSM-5 severity classification within the last 3 months (moderate to mild, or severe to mild or moderate) relative to study Baseline (yes/no) at Month 6 and Years 1, 2, and 3', 'timeFrame': 'up to a maximum of 4 years', 'description': 'DSM-5-Related'}, {'measure': 'Among those starting SUBLOCADE within 3 months of study Baseline, time to achieve early remission for the first time while on initial SUBLOCADE treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'DSM-5-Related'}, {'measure': 'Participants achieving DSM-5 sustained remission (yes/no) by 1, 1.5, 2, 2.5, and 3 years while on initial SUBLOCADE treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'DSM-5-Related'}, {'measure': 'Time to achieve sustained remission for the first time while on initial SUBLOCADE treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'DSM-5-Related'}, {'measure': 'Time to discontinuing initial SUBLOCADE treatment and the corresponding reasons for discontinuation, eg, resolution of OUD symptoms, safety concerns, treatment failure, or seeking alternative MOUD treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'MOUD Use and Retention'}, {'measure': 'Participants switching from initial SUBLOCADE treatment to another MOUD (yes/no), and the corresponding reasons, eg, safety concerns, treatment failure, seeking alternative MOUD treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'MOUD Use and Retention'}, {'measure': 'The overall treatment duration for participants who stop initial SUBLOCADE treatment as the result of resolution of OUD symptoms', 'timeFrame': 'up to a maximum of 4 years', 'description': 'MOUD Use and Retention'}, {'measure': 'Participants with any positive opioid use in the past month (yes/no) at Month 6 and Years 1, 2, and 3 while on initial SUBLOCADE treatment', 'timeFrame': 'up to a maximum of 4 years', 'description': 'Illicit Opioid Use (Self-Reports)'}, {'measure': 'Participants with opioid overdose requiring intervention (yes/no) while on initial SUBLOCADE treatment at least once during the first 6 months, and during Years 1, 2, and 3', 'timeFrame': 'up to a maximum of 4 years', 'description': 'Opioid Overdose Requiring Intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medicine for Opioid Use Disorder (MOUD)'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': "This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.", 'detailedDescription': 'This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants may enroll if they have initiated treatment with SUBLOCADE within 3 months prior to signing the informed consent form (ICF), or have completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and received their last dose of SUBLOCADE on the study within 3 months prior to signing the ICF, and plan to receive additional SUBLOCADE injections.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Is an adult ≥ 18 years of age who has signed the informed consent form\n* Plans to receive additional SUBLOCADE injections and\n\n * Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit\n\n * OR\n * Has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit\n* Is not currently participating in any clinical trial requiring medical intervention\n* Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence'}, 'identificationModule': {'nctId': 'NCT05860959', 'briefTitle': 'SUBLOCADE Long-term Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Indivior Inc.'}, 'officialTitle': 'A Phase IV Longitudinal Study of SUBLOCADE (SUBUTEX Prolonged Release) Clinical Outcomes in Adults With Opioid Use Disorder (Opioid Dependence)', 'orgStudyIdInfo': {'id': 'INDV-6000-406'}}, 'contactsLocationsModule': {'locations': [{'zip': '92626', 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