Comparison · NCT02617628-sae
Before Re-entry vs After Re-entry: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Before Re-entry vs After Re-entry: serious adverse events. Trial comparisons, record NCT02617628-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02617628-sae
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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 | 0.135 | 0.0751 | 0.231 | wilson | |
| Risk in group 2 | 0.181 | 0.109 | 0.285 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0454 | -0.166 | 0.0746 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.748 | 0.351 | 1.6 | log | |
| Odds ratio, group 1 over group 2 | 0.709 | 0.289 | 1.74 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Before Re-entry than on After Re-entry | 22 | 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 | Before Re-entry | Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling. | 10 | 74 | EG000 |
| Group 2 | After Re-entry | Extended Release Naltrexone, 380 mg injection, 1x monthly for 4 months~Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling. | 13 | 72 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years, 2 months
Source ClinicalTrials.gov
Trial
- Title
- Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone
- NCT number
- NCT02617628
- Phases
- PHASE2, PHASE3
- Conditions
- Opiate Dependence
- Interventions
- extended release naltrexone
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2020-04-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02617628?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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