Comparison · NCT00604188-sae
Direct Suboxone Induction vs Subutex-to-Suboxone Induction: 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. Direct Suboxone Induction vs Subutex-to-Suboxone Induction: serious adverse events. Trial comparisons, record NCT00604188-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00604188-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 | 0.0108 | 0.0019 | 0.0584 | wilson | |
| Risk in group 2 | 0.0319 | 0.0109 | 0.0897 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0212 | -0.0796 | 0.0309 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.337 | 0.0357 | 3.18 | log | |
| Odds ratio, group 1 over group 2 | 0.33 | 0.0337 | 3.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Direct Suboxone Induction than on Subutex-to-Suboxone Induction | 47.3 | 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 | Direct Suboxone Induction | Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. | 1 | 93 | EG000 |
| Group 2 | Subutex-to-Suboxone Induction | Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day. | 3 | 94 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
- NCT number
- NCT00604188
- Phases
- PHASE4
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Interventions
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2011-05-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00604188?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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