Trial · NCT02357901
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
NCT02357901, Phase 3, Completed, Indivior Inc.; results first posted 2018-02-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine. Trials, record NCT02357901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02357901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
- NCT number
- NCT02357901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- Indivior Inc.
- Conditions
- Opioid Dependence, Opioid Related Disorders
- Interventions
- SUBOXONE, RBP-6000, Placebo
- First posted
- 2015-02-06
- Last updated
- 2018-02-20
- Results first posted
- 2018-02-20
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Weekly from Weeks 5-24 | 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. |
| Secondary | Percentage of Participants Considered A Treatment Success | Weeks 5-24 | 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. |
| Secondary | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 | Weekly from Weeks 5-24 | 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. |
| Secondary | Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 | Weekly from Weeks 5-24 | 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. |
| 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 | Baseline: Day 1 (prior to dosing), Weeks 5-24 | 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. |
| Secondary | Participants Who Complete the Week 24 Visit ("Completers") | Week 24 | 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. |
| Secondary | Participants Who Are Abstinent at Week 24 | Week 24 | Participants with both a negative urine sample and negative self-report for illicit opioid use at 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 | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 | 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. |
| 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 | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 | 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. |
| Secondary | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | 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 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Weekly from Weeks 5-24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Considered A Treatment Success | Weeks 5-24 | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24 | Weekly from Weeks 5-24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24 | Weekly from Weeks 5-24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline: Day 1 (prior to dosing), Weeks 5-24 | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Participants Who Complete the Week 24 Visit (Completers) | Week 24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Are Abstinent at Week 24 | Week 24 | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | units on a scale | LEAST_SQUARES_MEAN |
| 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 | Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169 | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures | 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 | Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group168
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | RBP-6000 300mg/100mg | >=0% | 194 | Participants | |
| 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 | RBP-6000 300mg/300mg | >=0% | 196 | Participants | |
| 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 | Combined Placebo | >=0% | 99 | Participants | |
| 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 | RBP-6000 300mg/100mg | >=10% | 139 | Participants | |
| 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 | RBP-6000 300mg/300mg | >=10% | 126 | Participants | |
| 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 | Combined Placebo | >=10% | 11 | Participants | |
| 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 | RBP-6000 300mg/100mg | >=20% | 115 | Participants | |
| 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 | RBP-6000 300mg/300mg | >=20% | 111 | Participants | |
| 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 | Combined Placebo | >=20% | 7 | Participants | |
| 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 | RBP-6000 300mg/100mg | >=30% | 101 | Participants |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-In Period (Days -14 to Day -1) | STARTED | Run-In Period | 665 | |
| Run-In Period (Days -14 to Day -1) | STARTED | RBP-6000 300mg/100mg | 0 | |
| Run-In Period (Days -14 to Day -1) | STARTED | RBP-6000 300mg/300mg | 0 | |
| Run-In Period (Days -14 to Day -1) | STARTED | Combined Placebo | 0 | |
| Run-In Period (Days -14 to Day -1) | COMPLETED | Run-In Period | 504 | |
| Run-In Period (Days -14 to Day -1) | COMPLETED | RBP-6000 300mg/100mg | 0 | |
| Run-In Period (Days -14 to Day -1) | COMPLETED | RBP-6000 300mg/300mg | 0 | |
| Run-In Period (Days -14 to Day -1) | COMPLETED | Combined Placebo | 0 | |
| Run-In Period (Days -14 to Day -1) | NOT COMPLETED | Run-In Period | 161 | |
| Run-In Period (Days -14 to Day -1) | NOT COMPLETED | RBP-6000 300mg/100mg | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | RBP-6000 300mg/100mg | 19 | 203 | |
| other | Headache | Nervous system disorders | RBP-6000 300mg/300mg | 17 | 201 | |
| other | Headache | Nervous system disorders | Combined Placebo | 6 | 100 | |
| other | Constipation | Gastrointestinal disorders | RBP-6000 300mg/100mg | 19 | 203 | |
| other | Constipation | Gastrointestinal disorders | RBP-6000 300mg/300mg | 16 | 201 | |
| other | Constipation | Gastrointestinal disorders | Combined Placebo | 0 | 100 | |
| other | Nausea | Gastrointestinal disorders | RBP-6000 300mg/100mg | 18 | 203 | |
| other | Nausea | Gastrointestinal disorders | RBP-6000 300mg/300mg | 16 | 201 | |
| other | Nausea | Gastrointestinal disorders | Combined Placebo | 5 | 100 | |
| other | Injection site pruritus | General disorders | RBP-6000 300mg/100mg | 13 | 203 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RBP-6000 300mg/100mg | 0 | 203 |
| Total, all-cause mortality | RBP-6000 300mg/300mg | 1 | 201 |
| Total, all-cause mortality | Combined Placebo | 0 | 100 |
| Total, other adverse events | RBP-6000 300mg/100mg | 97 | 203 |
| Total, other adverse events | RBP-6000 300mg/300mg | 84 | 201 |
| Total, other adverse events | Combined Placebo | 27 | 100 |
| Total, serious adverse events | RBP-6000 300mg/100mg | 4 | 203 |
| Total, serious adverse events | RBP-6000 300mg/300mg | 7 | 201 |
| Total, serious adverse events | Combined Placebo | 5 | 100 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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