Trial · NCT04995029
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
NCT04995029, Phase 4, Completed, Indivior Inc.; results first posted 2025-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users. Trials, record NCT04995029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04995029
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
- NCT number
- NCT04995029
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 785 participants, actual
- Lead sponsor
- Indivior Inc.
- Conditions
- Moderate to Severe Opioid-use Disorder
- Interventions
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- First posted
- 2021-08-06
- Last updated
- 2026-02-06
- Results first posted
- 2025-09-25
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Weeks 20 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 20 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Primary | Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Week 2 | Treatment retention at Injection 2 was defined as the proportion of participants receiving Injection 2 at the Week 2 Visit among those in the Evaluable Population for Treatment Retention/Discontinuation. Participants who received Injection 2 at Week 2 (nominal) Visit and those who missed Injection 2 at Week 2 (nominal) Visit but received Injection 3 at the Week 6 Day 36 Visit were counted as "Yes" for treatment retention at Injection 2; otherwise, participants were counted as "No". |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38 | Weeks 10 to 38 | Participants' percentage of days opioids were used out of days assessed over Weeks 10 to 38 (inclusive), based on the TLFB for the prior week. |
| Secondary | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Weeks 10 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% over Weeks 10 to 38 inclusive. Opioid abstinence is defined as a negative urine drug screen (UDS) result and negative responses to the TimeLine Follow Back (TLFB) interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. Opioid use will be assessed at 15 visits between Weeks 10 and 38. |
| Secondary | Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38 | Weeks 10 to 38 | Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38 | Week 30 to 38 | A responder for weekly opioid use is defined as a participant whose percentage of visits with opioid abstinence is greater than or equal to 80% for the last 5 visits planned for urine drug screen (UDS) and TimeLine Follow Back (TLFB) over Weeks 30 to 38 (inclusive). Opioid abstinence is defined as a negative UDS result and negative responses to the TLFB interview for opioid use. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Responders for Daily Opioid Use | Week 30 to 38 | A responder for daily opioid use is defined as a participant with 20% or less days of opioid use, based on the TimeLine Follow Backs (TLFBs) collected at the last 5 observed visits post randomization. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall | Week 2 to 38 | Opioid abstinence is defined as negative urine drug screen results and negative responses to the TimeLine Follow Back (TLFB) interview for opioids at all assessments between Weeks 2 and 38. The TLFB asks participants to retrospectively estimate their daily drug use for each of the past 7 days prior to the visit. |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Overall | Week 2 to 38 | For each participant, the percentage of days opioids were used out of days assessed over Weeks 2 to 38 (inclusive), based on the TimeLine Follow Back (TLFB) for the prior week of each visit. |
| Secondary | Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route | Weeks 10 to 38 | For participants who use opioids via the injection route for an average of 5 or more days per week in the last 4 weeks prior to Screening, the percentage of days opioids were used via the injection route out of days assessed based on the Timeline Follow Back (TLFB) interview for the prior week of each visit. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Weeks 20 to 38 | The Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Week 2 | Evaluable Population for Treatment Retention/Discontinuation: For analysis pertaining to treatment retention and time to treatment discontinuation, the Substudy Full Analysis Set participants who discontinued treatment due to not meeting inclusion/exclusion criteria were also excluded. The participants were analyzed corresponding to the induction arm they received (as treated, ie, actual arm). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38 | Weeks 10 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomised, and received at least 1 maintenance RBP-6000 injection post DB Randomisation. Participants were analysed according to the randomised treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants' Percentage of Days | MEAN |
| SECONDARY | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Weeks 10 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38 | Weeks 10 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants' Percentage of Visits | MEAN |
| SECONDARY | Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38 | Week 30 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maintenance Phase: Percentage of Responders for Daily Opioid Use | Week 30 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maintenance Phase: Percentage of Visits With Opioid Abstinence Overall | Week 2 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants' Percentage of Visits | MEAN |
| SECONDARY | Maintenance Phase: Percentage of Days Opioids Were Used Overall | Week 2 to 38 | Full Analysis Set (FAS): Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization. Participants were analyzed according to the randomized treatment arm. This population served as the primary analysis population for efficacy analyses. | Participants' Percentage of Days | MEAN |
| SECONDARY | Maintenance Phase: Percentage of Days Opioids Were Used Via the Injection Route | Weeks 10 to 38 | Full Analysis Set (FAS) Subpopulation: Participants who met all inclusion/exclusion criteria, were randomized, and received at least 1 maintenance RBP-6000 injection post DB Randomization; for this analysis, only participants who use opioids via the injection route for an average of ≥5 days per week in the last 4 weeks prior to Screening were included. Participants were analyzed according to the randomized treatment arm. | Participants' Percentage of Days | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Maintenance Phase: Extended-release Buprenorphine 100 mg | 44 | Participants | ||
| Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Maintenance Phase: Extended-release Buprenorphine 300 mg | 50 | Participants | ||
| Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Induction Phase: Rapid Induction | 312 | Participants | ||
| Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Induction Phase: Standard of Care Induction | 138 | Participants | ||
| Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 100 mg | 17.7 | Standard Deviation 27.80 | Participants' Percentage of Days | |
| Maintenance Phase: Percentage of Days Opioids Were Used Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 300 mg | 15.9 | Standard Deviation 26.13 | Participants' Percentage of Days | |
| Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 100 mg | 42 | Participants | ||
| Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 300 mg | 45 | Participants | ||
| Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 100 mg | 31.1 | Standard Deviation 37.18 | Participants' Percentage of Visits | |
| Maintenance Phase: Percentage of Visits With Opioid Abstinence Over Weeks 10 to 38 | Maintenance Phase: Extended-release Buprenorphine 300 mg | 32.1 | Standard Deviation 36.94 | Participants' Percentage of Visits |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | Induction Phase: Rapid Induction | 518 | |
| Induction Phase | STARTED | Induction Phase: Standard of Care Induction | 267 | |
| Induction Phase | STARTED | Maintenance Phase: Extended-release Buprenorphine 100 mg | 0 | |
| Induction Phase | STARTED | Maintenance Phase: Extended-release Buprenorphine 300 mg | 0 | |
| Induction Phase | Received TM BUP | Induction Phase: Rapid Induction | 513 | |
| Induction Phase | Received TM BUP | Induction Phase: Standard of Care Induction | 264 | |
| Induction Phase | Received TM BUP | Maintenance Phase: Extended-release Buprenorphine 100 mg | 0 | |
| Induction Phase | Received TM BUP | Maintenance Phase: Extended-release Buprenorphine 300 mg | 0 | |
| Induction Phase | Received RBP-6000 Injection 1 | Induction Phase: Rapid Induction | 444 | |
| Induction Phase | Received RBP-6000 Injection 1 | Induction Phase: Standard of Care Induction | 159 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events148
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 | Nausea | Gastrointestinal disorders | Induction Phase: Rapid Induction | 65 | 474 | |
| other | Nausea | Gastrointestinal disorders | Induction Phase: Standard of Care Induction | 31 | 255 | |
| other | Nausea | Gastrointestinal disorders | Maintenance Phase: Extended-release Buprenorphine 100 mg | 0 | 218 | |
| other | Nausea | Gastrointestinal disorders | Maintenance Phase: Extended-release Buprenorphine 300 mg | 0 | 217 | |
| other | Vomiting | Gastrointestinal disorders | Induction Phase: Rapid Induction | 32 | 474 | |
| other | Vomiting | Gastrointestinal disorders | Induction Phase: Standard of Care Induction | 15 | 255 | |
| other | Vomiting | Gastrointestinal disorders | Maintenance Phase: Extended-release Buprenorphine 100 mg | 0 | 218 | |
| other | Vomiting | Gastrointestinal disorders | Maintenance Phase: Extended-release Buprenorphine 300 mg | 0 | 217 | |
| other | Anxiety | Psychiatric disorders | Induction Phase: Rapid Induction | 50 | 474 | |
| other | Anxiety | Psychiatric disorders | Induction Phase: Standard of Care Induction | 21 | 255 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Phase: Rapid Induction | 1 | 474 |
| Total, all-cause mortality | Induction Phase: Standard of Care Induction | 0 | 255 |
| Total, all-cause mortality | Maintenance Phase: Extended-release Buprenorphine 100 mg | 0 | 218 |
| Total, all-cause mortality | Maintenance Phase: Extended-release Buprenorphine 300 mg | 1 | 217 |
| Total, other adverse events | Induction Phase: Rapid Induction | 135 | 474 |
| Total, other adverse events | Induction Phase: Standard of Care Induction | 58 | 255 |
| Total, other adverse events | Maintenance Phase: Extended-release Buprenorphine 100 mg | 11 | 218 |
| Total, other adverse events | Maintenance Phase: Extended-release Buprenorphine 300 mg | 30 | 217 |
| Total, serious adverse events | Induction Phase: Rapid Induction | 7 | 474 |
| Total, serious adverse events | Induction Phase: Standard of Care Induction | 1 | 255 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Maintenance Phase: Extended-release Buprenorphine 100 mg vs Maintenance Phase: Extended-release Buprenorphine 300 mg: Maintenance Phase: Percentage of Participants Who Complete the Last Scheduled Injection | Trial comparisons |
| Induction Phase: Rapid Induction vs Induction Phase: Standard of Care Induction: Induction Phase: Number of Participants With Adverse Events Between Injections 2 and 3 | Trial comparisons |
| Maintenance Phase: Extended-release Buprenorphine 100 mg vs Maintenance Phase: Extended-release Buprenorphine 300 mg: Maintenance Phase: Percentage of Responders for Daily Opioid Use | Trial comparisons |
| Induction Phase: Rapid Induction vs Induction Phase: Standard of Care Induction: Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit | Trial comparisons |
Maintenance Phase: Extended-release Buprenorphine 100 mg vs Maintenance Phase: Extended-release Buprenorphine 300 mg: Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 to 38 | Trial comparisons |
Maintenance Phase: Extended-release Buprenorphine 100 mg vs Maintenance Phase: Extended-release Buprenorphine 300 mg: Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 10 to 38 | Trial comparisons |
| Induction Phase: Rapid Induction vs Induction Phase: Standard of Care Induction: Induction Phase: Number of Participants With Adverse Events up to Injection 2 | Trial comparisons |
Maintenance Phase: Extended-release Buprenorphine 100 mg vs Maintenance Phase: Extended-release Buprenorphine 300 mg: Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38 | Trial comparisons |
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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04995029
GET https://conductscience.org/api/trials/v1/NCT04995029/results?page=2