Comparison · NCT04995029-84f782e2
Induction Phase: Rapid Induction vs Induction Phase: Standard of Care Induction: Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
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. 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, record NCT04995029-84f782e2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04995029-84f782e2
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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 | 0.664 | 0.62 | 0.705 | wilson | |
| Risk in group 2 | 0.545 | 0.484 | 0.606 | wilson | |
| Risk difference, group 1 minus group 2 | 0.118 | 0.0439 | 0.192 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 1.07 | 1.39 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 1.2 | 2.25 | log | |
| Number needed to treat, for one more participant with the outcome on Induction Phase: Rapid Induction than on Induction Phase: Standard of Care Induction | 8.45 | 5.2 | 22.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Induction Phase: Rapid Induction | Participants will receive 4 mg transmucosal buprenorphine on Day 1. Participants meeting eligibility requirements will then receive 300 mg extended-release buprenorphine by subcutaneous injection at least 1 hour later and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).~Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)~Extended-release Buprenorphine: Administered by subcutaneous injection | 312 | 470 | OG000 |
| Group 2 | Induction Phase: Standard of Care Induction | Participants will receive transmucosal buprenorphine for a minimum of 7 days per applicable product labelling information. Participants meeting eligibility requirements will receive 300 mg extended-release buprenorphine by subcutaneous injection on Day 1 and a second dose on Day 8. Participants are followed until Injection 3 (Week 6).~Transmucosal Buprenorphine: Transmucosal (TM) buprenorphine as selected by the Investigator per local prescribing guidelines, administered either under the tongue (sublingual) or between the gum and cheek (buccal)~Extended-release Buprenorphine: Administered by subcutaneous injection | 138 | 253 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Induction Phase: Percentage of Participants Receiving Injection 2 at the Week 2 Visit
- Description
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.
- Time frame
- Week 2
- Population
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).
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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