Comparison · NCT04995029-e65b1797
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT04995029-e65b1797. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04995029-e65b1797
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.229 | 0.179 | 0.29 | wilson | |
| Risk in group 2 | 0.259 | 0.205 | 0.322 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0299 | -0.11 | 0.0509 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.885 | 0.635 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.85 | 0.548 | 1.32 | log | |
| Number needed to treat, for one fewer participant with the outcome on Maintenance Phase: Extended-release Buprenorphine 100 mg than on Maintenance Phase: Extended-release Buprenorphine 300 mg | 33.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Maintenance Phase: Extended-release Buprenorphine 100 mg | Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 100 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.~Extended-release Buprenorphine: Administered by subcutaneous injection | 50 | 218 | OG000 |
| Group 2 | Maintenance Phase: Extended-release Buprenorphine 300 mg | Participants eligible to continue treatment will be randomized at Week 6 to receive maintenance doses of 300 mg extended-release buprenorphine by subcutaneous injection every 4 weeks for a total of up to 8 maintenance injections (Weeks 6 to 34). Participants are followed until Week 38.~Extended-release Buprenorphine: Administered by subcutaneous injection | 56 | 216 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 30 to 38
- Description
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.
- Time frame
- Week 30 to 38
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
- NCT number
- NCT04995029
- Phases
- PHASE4
- Conditions
- Moderate to Severe Opioid-use Disorder
- Interventions
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Lead sponsor
- Indivior Inc.
- Results first posted
- 2025-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04995029?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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