Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
After completing an up to 2-week screening period, subjects entered an open-label run-in induction phase with SUBOXONE (buprenorphine/naloxone) sublingual film for 3 days followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information.
This is a 24-week non-residential study with participants being randomized after meeting randomization criteria. On Day 1 and Day 29 (± 2 days) participants will receive subcutaneous injections of 300 mg RBP-6000 or placebo. Thereafter, participants will receive 4 injections (once every 28 days ± 2 days) of either 300 mg or 100 mg RBP-6000 doses or placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBP-6000 300mg/100mg | Experimental | During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 are separated by 28 days (Day 57-Day 141) and contain RBP-6000 100 mg. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
| RBP-6000 300mg/300mg | Experimental | During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
| Placebo Matching 300 mg/100 mg RBP-6000 | Placebo Comparator | During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given placebo injections on Days 1 and 29 (matching the RBP-6000 300 mg dose volume). Injections 3-6 are separated by 28 days (Day 57-Day 141) and also contain placebo (matching the RBP-6000 100 mg volume). In addition, participants received individual drug counseling (IDC) at least once a week. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUBOXONE | Drug | SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 | 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 primary 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. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-negative. | Weekly from Weeks 5-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Considered A Treatment Success | Treatment success is defined as a participant having ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24. | Weeks 5-24 |
| Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Director Global 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 |
|---|---|---|---|
| 38042801 | Derived | Greenwald MK, Wiest KL, Haight BR, Laffont CM, Zhao Y. Examining the benefit of a higher maintenance dose of extended-release buprenorphine in opioid-injecting participants treated for opioid use disorder. Harm Reduct J. 2023 Dec 2;20(1):173. doi: 10.1186/s12954-023-00906-7. | |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 36 sites in the United States screened subjects in this study. Three sites did not randomize any subjects.
Analyses of RB-US-13-0001 were planned, conducted, and reported with pooled placebo groups.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Run-In Period | During the Run-In Period, participants were inducted onto SUBOXONE sublingual film followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In Period (Days -14 to Day -1) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo Matching 300 mg RBP-6000 | Placebo Comparator | During the Run-In Period, participants are inducted onto SUBOXONE sublingual film (SL) followed by a 4- to 11-day SUBOXONE sublingual film open-label run-in dose-adjustment period to achieve buprenorphine dosages ranging from 8 to 24 mg according to the SUBOXONE sublingual film prescribing information. Participants are then randomized. As of protocol Amendment 2 (21 August 2015) SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. Participants in this treatment arm are given six placebo injections (volume-matched to RBP-6000 300 mg dose) on Days 1 to 141 with injections separated by 28 days. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| RBP-6000 | Drug | Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose. |
|
|
| Placebo | Drug | Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug. |
|
|
Data represent the count of participants at various percentage levels in which urine samples tested negative for opioids. All missing reports for urine samples were considered non-negative. |
| Weekly from Weeks 5-24 |
| Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 | Data represent the count of participants at various percentage levels in which self-reports were negative for illicit use of opioids. Self-reports were obtained from Timeline Followback (TLFB) interviews. All missing self-reports were considered non-negative. | Weekly from Weeks 5-24 |
| Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The opioid craving scale was a 100 mm scale with 0= 'no craving' on the left end and 100= 'strongest craving ever' on the right end of the scale. Participants marked where along the scale reflected their craving for opioids. The full range of the change from baseline scale was therefore 100 (no craving at baseline, strongest craving during study) to -100 (strongest craving at baseline, no craving during study). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The opioid craving VAS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Negative change from baseline values indicate a lessening of craving symptoms. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Baseline: Day 1 (prior to dosing), Weeks 5-24 |
| Participants Who Complete the Week 24 Visit ("Completers") | A completer was defined as a participant who completed either the urine drug screen (UDS) or Timeline Followback (TLFB) assessment at the Week 24 visit. | Week 24 |
| Participants Who Are Abstinent at Week 24 | Participants with both a negative urine sample and negative self-report for illicit opioid use at Week 24. | Week 24 |
| Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The CGI-I was used to rate the change in clinical status since the start of the treatment on an ordinal scale ranging from 1 (very much improved; nearly all better; good level of functioning; minimal symptoms; represents a very substantial change) to 7 (very much worse; severe exacerbation of symptoms and loss of functioning). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment. Negative change from baseline values indicate an improved clinical global impression. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 |
| Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The CGI-S was an assessment completed by the clinician to rate the severity of symptoms on an ordinal scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects; pathology drastically interferes in many life functions). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment. Negative change from baseline values indicate an improvement in the severity of symptoms. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 |
| Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal (Wesson et al., 1999). 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. The COWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. | Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169 |
| Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | 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. The SOWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. | Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169 |
| Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 | The total number of weeks of abstinence was assessed from urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. All missing reports for opioids were considered non-negative. | Weeks 5 through 24 |
| Participants With Adverse Events During the Treatment Period | Treatment-emergent adverse event (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 through Week 24 |
| Worst Injection Site Pain From Injections 1-6 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' on the left end and 'strongest pain ever' on the right end of the scale (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, 60 and 120 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 6 injections and all VAS records. The mean value is presented. | Days 1, 29, 57, 85, 113, 141 |
| Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24 | 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. The C-SSRS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. | Weekly - Week 2 through Week 24 |
| 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 |
| North County Clinical Research | Oceanside | California | 92056 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Care Practice | San Francisco | California | 94103 | United States |
| Southern California Research | Thousand Oaks | California | 91360 | United States |
| Amit Vijapura | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Lakeland | Florida | 38805 | 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 |
| Behavioral Health Care Associates | Schaumburg | Illinois | 60194 | 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 |
| 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 |
| 36467036 | Derived | Laffont CM, Ngaimisi E, Gopalakrishnan M, Ivaturi V, Young M, Greenwald MK, Heidbreder C. Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder. Front Pharmacol. 2022 Nov 18;13:1052113. doi: 10.3389/fphar.2022.1052113. eCollection 2022. |
| 35287034 | Derived | 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. |
| 34794061 | Derived | Boyett B, Wiest K, McLeod LD, Nelson LM, Bickel WK, Learned SM, Heidbreder C, Fudala PJ, Le Moigne A, Zhao Y. Assessment of craving in opioid use disorder: Psychometric evaluation and predictive validity of the opioid craving VAS. Drug Alcohol Depend. 2021 Dec 1;229(Pt B):109057. doi: 10.1016/j.drugalcdep.2021.109057. Epub 2021 Sep 24. |
| 32920647 | Derived | Kranzler HR, Lynch KG, Crist RC, Hartwell E, Le Moigne A, Laffont CM, Andorn AC. A Delta-Opioid Receptor Gene Polymorphism Moderates the Therapeutic Response to Extended-Release Buprenorphine in Opioid Use Disorder. Int J Neuropsychopharmacol. 2021 Feb 15;24(2):89-96. doi: 10.1093/ijnp/pyaa069. |
| 30792007 | Derived | Haight BR, Learned SM, Laffont CM, Fudala PJ, Zhao Y, Garofalo AS, Greenwald MK, Nadipelli VR, Ling W, Heidbreder C; RB-US-13-0001 Study Investigators. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2019 Feb 23;393(10173):778-790. doi: 10.1016/S0140-6736(18)32259-1. Epub 2019 Feb 18. |
| RBP-6000 300mg/100mg |
Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| FG002 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| FG003 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period (Day 1 to Week 24) |
|
|
Safety analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RBP-6000 300mg/100mg | Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| BG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| BG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| BG003 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Tobacco use | Count of Participants | Participants |
| ||||||||||||||||
| Caffeine use | Count of Participants | Participants |
| ||||||||||||||||
| Alcohol use | Count of Participants | Participants |
| ||||||||||||||||
| Drug use history | Count of Participants | Participants |
|
| 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 | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 | 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 primary 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. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-negative. | Full analysis set | Posted | Count of Participants | Participants | Weekly from Weeks 5-24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Considered A Treatment Success | Treatment success is defined as a participant having ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24. | Full analysis set | Posted | Number | percentage of participants | Weeks 5-24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 | Data represent the count of participants at various percentage levels in which urine samples tested negative for opioids. All missing reports for urine samples were considered non-negative. | Full analysis set | Posted | Count of Participants | Participants | Weekly from Weeks 5-24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 | Data represent the count of participants at various percentage levels in which self-reports were negative for illicit use of opioids. Self-reports were obtained from Timeline Followback (TLFB) interviews. All missing self-reports were considered non-negative. | Full analysis set | Posted | Count of Participants | Participants | Weekly from Weeks 5-24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The opioid craving scale was a 100 mm scale with 0= 'no craving' on the left end and 100= 'strongest craving ever' on the right end of the scale. Participants marked where along the scale reflected their craving for opioids. The full range of the change from baseline scale was therefore 100 (no craving at baseline, strongest craving during study) to -100 (strongest craving at baseline, no craving during study). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The opioid craving VAS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Negative change from baseline values indicate a lessening of craving symptoms. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline: Day 1 (prior to dosing), Weeks 5-24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Who Complete the Week 24 Visit ("Completers") | A completer was defined as a participant who completed either the urine drug screen (UDS) or Timeline Followback (TLFB) assessment at the Week 24 visit. | Full analysis set | Posted | Count of Participants | Participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Who Are Abstinent at Week 24 | Participants with both a negative urine sample and negative self-report for illicit opioid use at Week 24. | Full analysis set | Posted | Count of Participants | Participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The CGI-I was used to rate the change in clinical status since the start of the treatment on an ordinal scale ranging from 1 (very much improved; nearly all better; good level of functioning; minimal symptoms; represents a very substantial change) to 7 (very much worse; severe exacerbation of symptoms and loss of functioning). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment. Negative change from baseline values indicate an improved clinical global impression. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures | The CGI-S was an assessment completed by the clinician to rate the severity of symptoms on an ordinal scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects; pathology drastically interferes in many life functions). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment. Negative change from baseline values indicate an improvement in the severity of symptoms. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect. | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal (Wesson et al., 1999). 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. The COWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | 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. The SOWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24 | The total number of weeks of abstinence was assessed from urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. All missing reports for opioids were considered non-negative. | Full analysis set | Posted | Least Squares Mean | Standard Error | weeks | Weeks 5 through 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Adverse Events During the Treatment Period | Treatment-emergent adverse event (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 | Day 1 through Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Worst Injection Site Pain From Injections 1-6 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' on the left end and 'strongest pain ever' on the right end of the scale (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, 60 and 120 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 6 injections and all VAS records. The mean value is presented. | Safety population | Posted | Mean | Standard Deviation | units on a scale | Days 1, 29, 57, 85, 113, 141 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24 | 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. The C-SSRS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21. | Safety analysis set of participants who completed a C-SSRS during the treatment period. | Posted | Count of Participants | Participants | Weekly - Week 2 through Week 24 |
|
Day 1 to Week 24
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RBP-6000 300mg/100mg | Participants were given RBP-6000 300 mg injections on Days 1 and 29. Injections 3-6 were separated by 28 days (Day 57-Day 141) and contained RBP-6000 100 mg. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. | 0 | 203 | 4 | 203 | 97 | 203 |
| EG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. | 1 | 201 | 7 | 201 | 84 | 201 |
| EG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. | 0 | 100 | 5 | 100 | 27 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Extradural abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Myelomalacia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 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 |
| 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
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Protocol Violation |
|
| Withdrawal symptoms |
|
| Non-compliance with study drug |
|
| Subject withdrawn by investigator |
|
| Physician Decision |
|
| site closed by sponsor, incarceration... |
|
| >=30 to <45 years |
|
| >=45 to <60 years |
|
| >= 60 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| No |
|
| No |
|
| Cocaine |
|
| Amphetamines/ Methamphetamine |
|
| Methadone |
|
| Cannabinoids |
|
| Barbiturates |
|
| Buprenorphine |
|
| Benzodiazepines |
|
| Phencyclidine |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| >=20% |
|
| >=30% |
|
| >=40% |
|
| >=50% |
|
| >=60% |
|
| >=70% |
|
| >=80% |
|
| >=90% |
|
significance at the 0.025 level |
| Superiority |
|
|
|
Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days.
As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
In addition, participants received individual drug counseling (IDC) at least once a week.
|
|
|
Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| OG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
|
|
|
|
|
|
| OG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| OG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| OG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| OG001 | RBP-6000 300mg/300mg | Participants were given six RBP-6000 300 mg injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| Combined Placebo |
Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
|
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
| OG002 | Combined Placebo | Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|
| OG002 |
| Combined Placebo |
Participants randomized to either of the two placebo treatment arms were combined into this one treatment arm for reporting purposes. Analyses of 13-0001 were planned, conducted, and reported with pooled placebo groups. These participants were given six volume-matched placebo injections on Days 1 to 141 with injections separated by 28 days. As of protocol Amendment 2 (21 August 2015) SUBOXONE sublingual film use was tapered from 6 mg to 2 mg from Days 1-5 and then discontinued. In addition, participants received individual drug counseling (IDC) at least once a week. |
|
|