Comparison · NCT01549652-sae
Prevention of Opioid Withdrawal vs Prevention of Physical Dependence: 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. Prevention of Opioid Withdrawal vs Prevention of Physical Dependence: serious adverse events. Trial comparisons, record NCT01549652-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01549652-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 | 0 | 0.104 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0741 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0741 | 0.104 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Prevention of Opioid Withdrawal | Chronic back pain patients titrated onto sustained release oral morphine for 30 days, then were randomized to take either ondansetron 8 mg or matching placebo thirty minutes prior to naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may be administered at 0.8 mg/70 kg). Participants returned to their titrated morphine dose for one week and then returned for the opposite pre-treatment followed by naloxone-induced withdrawal in clinic. Participants then tapered back to their original dose of morphine for one week. | 0 | 33 | EG000 |
| Group 2 | Prevention of Physical Dependence | Chronic back pain patients titrated onto sustained release oral morphine for 30 days; during morphine treatment, participants were randomized to take either ondansetron 8 mg or matching placebo three times daily along with the oral morphine treatment. After thirty days, participants returned to the lab to undergo naloxone-induced withdrawal in clinic (naloxone dose: 0.4 mg/70 kg; if deemed necessary by the clinician to induce withdrawal, a second naloxone dose may have been administered at 0.8 mg/70 kg). Participants then tapered back to their original dose of morphine for one week. | 0 | 48 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- 5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
- NCT number
- NCT01549652
- Phases
- NA
- Conditions
- Opioid Withdrawal, Physical Dependence
- Interventions
- Ondansetron, Placebo, Morphine, Naloxone 0.4 mg/70 kg, Naloxone 0.8 mg/70 kg
- Lead sponsor
- Stanford University
- Results first posted
- 2019-01-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01549652?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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