Comparison · NCT04995029-aa47e82a
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
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 20 to 38. Trial comparisons, record NCT04995029-aa47e82a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04995029-aa47e82a
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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 | 0.202 | 0.154 | 0.26 | wilson | |
| Risk in group 2 | 0.231 | 0.18 | 0.292 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0296 | -0.107 | 0.0479 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.872 | 0.609 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.84 | 0.531 | 1.33 | 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 | 33.7 | 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 | 44 | 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 | 50 | 216 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Maintenance Phase: Percentage of Responders for Weekly Opioid Use Over Weeks 20 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% 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.
- Time frame
- Weeks 20 to 38
- Population
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.
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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