Comparison · NCT02478489-sae
Extended-release Injectable Naltrexone (XR-NTX) vs Oral Naltrexone (PO-NTX): serious adverse events
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. Extended-release Injectable Naltrexone (XR-NTX) vs Oral Naltrexone (PO-NTX): serious adverse events. Trial comparisons, record NCT02478489-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02478489-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 | 0.35 | 0.271 | 0.437 | wilson | |
| Risk in group 2 | 0.344 | 0.266 | 0.431 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00559 | -0.111 | 0.123 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.722 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.608 | 1.73 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Extended-release Injectable Naltrexone (XR-NTX) than on Oral Naltrexone (PO-NTX) | 179 | 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 | Extended-release Injectable Naltrexone (XR-NTX) | Monthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.~Extended-release injectable naltrexone (XR-NTX): injectable naltrexone | 43 | 123 | EG000 |
| Group 2 | Oral Naltrexone (PO-NTX) | Daily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.~Oral naltrexone (PO-NTX): oral naltrexone | 43 | 125 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected until the participant's 3-month follow-up research assessment was completed or their follow-up window closed.
Source ClinicalTrials.gov
Trial
- Title
- Alcohol Disorder hOsPital Treatment Trial
- NCT number
- NCT02478489
- Phases
- PHASE4
- Conditions
- Heavy Drinking, Alcohol Dependence, Alcohol Use Disorder
- Interventions
- Oral naltrexone (PO-NTX), Extended-release injectable naltrexone (XR-NTX)
- Lead sponsor
- Boston University
- Results first posted
- 2021-06-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02478489?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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