Comparison · NCT02737826-8cfbe5b0
Phase II - Gabapentin + Buprenorphine Taper vs Phase II - Placebo + Buprenorphine Taper: Number of Participants Who Achieve Opioid Cessation
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. Phase II - Gabapentin + Buprenorphine Taper vs Phase II - Placebo + Buprenorphine Taper: Number of Participants Who Achieve Opioid Cessation. Trial comparisons, record NCT02737826-8cfbe5b0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02737826-8cfbe5b0
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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 | 0.0769 | 0.0137 | 0.333 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0769 | -0.147 | 0.333 | 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 treat, for one more participant with the outcome on Phase II - Gabapentin + Buprenorphine Taper than on Phase II - Placebo + Buprenorphine Taper | 13 | 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 | Phase II - Gabapentin + Buprenorphine Taper | Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.~Gabapentin - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Placebo - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering. | 1 | 13 | OG000 |
| Group 2 | Phase II - Placebo + Buprenorphine Taper | Subjects who tolerate buprenorphine initiation in Phase I (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Buprenorphine - Phase I: In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol.~Gabapentin - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering.~Placebo - Phase II: Subjects who tolerate buprenorphine initiation (determined by pain level ≤ to baseline, withdrawal measures ≤ to baseline, and willingness to continue with taper) will proceed to Phase II, which will involve randomization to gabapentin or placebo, buprenorphine stabilization, and buprenorphine tapering. | 0 | 14 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Achieve Opioid Cessation
- Description
For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point.
- Time frame
- 8 weeks after stabilization at Week 10
- Population
Source ClinicalTrials.gov
Trial
- Title
- Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
- NCT number
- NCT02737826
- Phases
- NA
- Conditions
- Chronic Pain, Opioid Pain Medication
- Interventions
- Buprenorphine Initiation - Phase I, Gabapentin + Buprenorphine - Phase II, Placebo + Buprenorphine - Phase II, Buprenorphine taper - Phase II
- Lead sponsor
- Medical University of South Carolina
- Results first posted
- 2021-04-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02737826?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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