Comparison · NCT02696434-1deee08a
NTX + BUP vs PBO NTX + BUP: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
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. NTX + BUP vs PBO NTX + BUP: Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8. Trial comparisons, record NCT02696434-1deee08a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02696434-1deee08a
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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 | 0.686 | 0.55 | 0.797 | wilson | |
| Risk in group 2 | 0.76 | 0.626 | 0.857 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0737 | -0.241 | 0.1 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.903 | 0.709 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 0.691 | 0.287 | 1.66 | log | |
| Number needed to treat, for one fewer participant with the outcome on NTX + BUP than on PBO NTX + BUP | 13.6 | 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 | NTX + BUP | Naltrexone + buprenorphine~Naltrexone: daily dosing~Buprenorphine: daily dosing | 35 | 51 | OG000 |
| Group 2 | PBO NTX + BUP | Placebo naltrexone + buprenorphine~Placebo: daily dosing~Buprenorphine: daily dosing | 38 | 50 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8
- Description
Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale \[COWS\] \</=12 or Subjective Opiate Withdrawal Scale \[SOWS\] \</=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).
- Time frame
- 8 days
- Population
There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.
Source ClinicalTrials.gov
Trial
- Title
- Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
- NCT number
- NCT02696434
- Phases
- PHASE3
- Conditions
- Opioid Use Disorder
- Interventions
- Naltrexone, Placebo, Buprenorphine
- Lead sponsor
- Alkermes, Inc.
- Results first posted
- 2019-02-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02696434?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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