Comparison · NCT01936857-sae
Buprenorphine/Naloxone vs Methadone Maintenance Therapy: 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/Naloxone vs Methadone Maintenance Therapy: serious adverse events. Trial comparisons, record NCT01936857-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01936857-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 | 0.0709 | 0.039 | 0.126 | wilson | |
| Risk in group 2 | 0.0286 | 0.0112 | 0.0712 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0424 | -0.0109 | 0.0998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.48 | 0.797 | 7.73 | log | |
| Odds ratio, group 1 over group 2 | 2.6 | 0.794 | 8.48 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Buprenorphine/Naloxone than on Methadone Maintenance Therapy | 23.6 | 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 | Buprenorphine/Naloxone | Office based treatment of opioid dependence with buprenorphine/naloxone~Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. | 10 | 141 | EG000 |
| Group 2 | Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence.~Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. | 4 | 140 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years
Source ClinicalTrials.gov
Trial
- Title
- Buprenorphine to Improve HIV Care Engagement and Outcomes
- NCT number
- NCT01936857
- Phases
- PHASE4
- Conditions
- HIV, Substance Related Disorders
- Interventions
- Buprenorphine/naloxone, Methadone Maintenance Therapy
- Lead sponsor
- Oregon Health and Science University
- Results first posted
- 2020-06-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01936857?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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