Comparison · NCT00315341-sae
Buprenorphine/Nx vs Methadone: 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. Buprenorphine/Nx vs Methadone: serious adverse events. Trial comparisons, record NCT00315341-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00315341-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 | 0.0523 | 0.0383 | 0.0709 | wilson | |
| Risk in group 2 | 0.0865 | 0.0653 | 0.114 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0343 | -0.0649 | -0.006 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.604 | 0.398 | 0.916 | log | |
| Odds ratio, group 1 over group 2 | 0.582 | 0.372 | 0.911 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Buprenorphine/Nx than on Methadone | 29.2 | 15.4 | 167 | from the risk difference interval |
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 | Buprenorphine/Nx | For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant's clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. | 38 | 727 | EG000 |
| Group 2 | Methadone | For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens. | 45 | 520 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events (medical and/or psychiatric) assessment will initiate with participant randomization and will continue through 30 days post last dose of study medication administered. Study staff should contact each participant 30 days after study completion and/or discontinuation of study medication to follow-up on any adverse events continuing at study end and to determine whether the participant experienced any adverse events within the 30 days after discontinuing study medication.
Source ClinicalTrials.gov
Trial
- Title
- Starting Treatment With Agonist Replacement Therapies (START)
- NCT number
- NCT00315341
- Phases
- PHASE4
- Conditions
- Opiate-related Disorders
- Interventions
- Buprenorphine/naloxone, Methadone
- Lead sponsor
- University of California, Los Angeles
- Results first posted
- 2017-01-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00315341?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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