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A multi-center, open-label, long-term safety study in which approximately 600 subjects diagnosed with opioid use disorder will be enrolled. Following a screening period, all subjects will receive run in SUBOXONE sublingual film followed by an initial injection of open-label high dose (300 mg) RBP-6000. The RBP-6000 monthly injection dose can be adjusted to low dose (100 mg), and back to high dose, based on the medical judgment of the Investigator. Subjects will participate in the study for either 6 or 12 months.
Approximately 600 subjects diagnosed with opioid use disorder will be enrolled; approximately 300 subjects who completed the randomized,double-blind, placebo-controlled study NCT02357901 (RB-US-13-0001) ('roll-over' participants), and approximately 300 subjects who did not participate in study RB-US-13-0001 ('de novo' participants). Following informed consent and completion of screening procedures, all subjects will receive SUBOXONE sublingual film, titrated to response.
After 4-14 days of SUBOXONE sublingual film treatment, subjects will be evaluated for enrollment into the study. Eligible subjects will receive 300 mg RBP-6000 as an initial dose, followed by monthly injections of 100 mg or 300 mg RBP-6000, based on the medical judgment of the investigator.
Subjects who participated in study RB-US-13-0001 ('roll-over' participants) will receive monthly injections for up to 6 months. Subjects who did not participate in study RB-US-13-0001 ('de novo' participants) will receive monthly injections for up to12 months.
At all injection visits continuous electrocardiogram recordings and pulse oximetry will be collected prior to injection and at least 4 hours after injection. Subjects will return to the clinic every 1-4 weeks for laboratory tests, complete study questionnaires, adverse event and injection site assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roll-over Subjects | Experimental | Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
|
| De Novo Subjects | Experimental | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUBOXONE sublingual film | Drug | SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. | Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm) |
| Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs | Vital signs include
Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1. | Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
| Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period | The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation. C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study. Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49) | COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. |
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Inclusion Criteria:
De novo subjects:
Roll-over subjects:
Exclusion Criteria:
De novo subjects:
Roll over subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Global Director Clinical Development | Indivior Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haleyville Clinical Research | Haleyville | Alabama | 35565 | United States | ||
| Boyett Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37657559 | Derived | Rutrick D, Learned SM, Boyett B, Hassman D, Shinde S, Zhao Y. 18-Month efficacy and safety analysis of monthly subcutaneous buprenorphine injection for opioid use disorder: Integrated analysis of phase 3 studies. J Subst Use Addict Treat. 2023 Nov;154:209155. doi: 10.1016/j.josat.2023.209155. Epub 2023 Aug 30. | |
| 35287034 | Derived |
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A total of 994 subjects were screened by 39 sites, and of those, 775 subjects entered the run-in period receiving at least 1 dose of SUBOXONE (508 de novo subjects and 267 roll-over subjects).
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| ID | Title | Description |
|---|---|---|
| FG000 | De Novo Subjects | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Run-In Period (Days -14 to Day -1) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Apr 14, 2015 | Jan 31, 2018 |
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|
|
| RBP-6000 | Drug | Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections. |
|
|
| Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
| Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS) | Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain. The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection. Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented. De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309. Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141. | De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141 |
| Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
| Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49) | The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. | Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
| Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49) | The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. | Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
| Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49) | Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB. Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative. | Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25 |
| Hamilton |
| Alabama |
| 35570 |
| United States |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
| Collaborative Neuroscience Network | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists | Glendale | California | 91206 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| Pacific Research Partners | Oakland | California | 94612 | United States |
| North County Clinical Research | Oceanside | California | 92056 | United States |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Amit Vijapura | Jacksonville | Florida | 32256 | United States |
| Sarkis Clinical Trials | Lake City | Florida | 32025 | United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Innovative Clinical Research | Lauderhill | Florida | 33319 | United States |
| Florida Clinical Research Center | Maitland | Florida | 32751 | United States |
| Try Research | Maitland | Florida | 32751 | United States |
| Scientific Clinical Research | North Miami | Florida | 33161 | United States |
| Research Centers of America | Oakland Park | Florida | 33334 | United States |
| Atlanta Institute of Medicine and Research | Alpharetta | Georgia | 30005 | United States |
| Phoenix Medical Research | Prairie Village | Kansas | 66206 | United States |
| Louisiana Research Associates | New Orleans | Louisiana | 70114 | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | United States |
| Stanley Street Treatment and Resources | Fall River | Massachusetts | 02720 | United States |
| Adams Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| Precise Research Centers, Inc. | Flowood | Mississippi | 39232 | United States |
| St Louis Clinical Trials | St Louis | Missouri | 63141 | United States |
| Altea Research | Las Vegas | Nevada | 89102 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Neuro-behavioral Clinical Research | Canton | Ohio | 44718 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | 44125 | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Pahl Pharmaceutical Professionals | Oklahoma City | Oklahoma | 73112 | United States |
| CODA | Portland | Oregon | 97214 | United States |
| Tipton Medical and Diagnostic Center aka Clinical Research Associates of Central PA | Altoona | Pennsylvania | 16602 | United States |
| UPenn Treatment Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| Carolina Clinical Trials | Charleston | South Carolina | 29407 | United States |
| Pillar Clinical Research | Dallas | Texas | 75243 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Aspen Clinical Research, LLC | Orem | Utah | 84058 | United States |
| Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9. |
| FG001 |
| Roll-over Subjects |
Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
Safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | De Novo Subjects | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. |
| BG001 | Roll-over Subjects | Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race | Count of Participants | Participants | No |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Waist-to-Hip Ratio | Waist-to-hip ratio is the ratio of the waist circumference to hip circumference (calculated by dividing the waist circumference by the hip circumference). It is a measurement of abdominal fat distribution. | Records for one participant were missing baseline waist-to-hip ratio. | Mean | Standard Deviation | ratio |
| |||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Tobacco use | Count of Participants | Participants | No |
| |||||||||||||||
| Caffeine use | Count of Participants | Participants | No |
| |||||||||||||||
| Alcohol use | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period | TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. | Safety analysis set | Posted | Count of Participants | Participants | No | Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs | Vital signs include
Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1. | Safety analysis set of participants with both a baseline and end of study reading | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
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| Primary | Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period | The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation. C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study. Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'. | Safety population. Four de novo subjects and one roll-over subject are not reported because they used the C-SSRS baseline version throughout the study. | Posted | Count of Participants | Participants | Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
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| Primary | Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS) | Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain. The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection. Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented. De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309. Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141. | Safety analysis set | Posted | Mean | Standard Deviation | units on a scale | De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141 |
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| Secondary | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49) | COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. | Safety analysis set | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
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| Secondary | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49) | The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. | Safety analysis set | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
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| Secondary | Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49) | The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids. Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values. | Safety analysis set | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm) |
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| Secondary | Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49) | Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB. Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative. | Safety analysis set | Posted | Count of Participants | Participants | Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25 |
|
Day 1 to Week 49 for De Novo arm Day 1 to Week 25 for the Roll-over arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | De Novo Subjects | Subjects who did not participate in RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 12 months in the Treatment period. | 0 | 412 | 16 | 412 | 146 | 412 |
| EG001 | Roll-over Subjects | Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. | 0 | 257 | 9 | 257 | 42 | 257 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Prostatic abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Adjustment disorder with mixed anxiety and depressed mood | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gallbladder perforation | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
|
Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Director, Clinical Development | Indivior, Inc. | 804-379-1090 | Robert.Bauer@Indivior.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Aug 19, 2015 | Jan 31, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Sep 11, 2015 | Jan 31, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Mar 25, 2016 | Jan 31, 2018 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2017 | Jan 31, 2018 | SAP_004.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 4 | Aug 4, 2016 | Mar 26, 2018 | Prot_005.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Withdrawn by the investigator |
|
| Protocol Violation |
|
| Incarceration, pregnancy, misc |
|
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|
|
|
|
|
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| >=1 serious TEAE |
|
| >=1 serious study treatment-related TEAE |
|
| Death |
|
| >=1 severe TEAE |
|
| TEAE leading to study treatment discontinuation |
|
| TEAE leading to dose reduction |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Roll-over Subjects |
Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
|
|
| Roll-over Subjects |
Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
|
|
|
|
|
|
|
|
| Roll-over Subjects |
Subjects who completed RB-US-13-0001 received SUBOXONE sublingual film during the Run-In period, followed by an initial open-label injection of 300 mg RBP-6000. Participants continued with monthly injections of either 300 mg or 100 mg (based on judgement of the Investigator) for a total of 6 months in the Treatment period. |
|
|