Comparison · NCT01335867-844973e2
Vigabatrin vs Placebo: Number of Participants With a Reduction in Cocaine Use
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. Vigabatrin vs Placebo: Number of Participants With a Reduction in Cocaine Use. Trial comparisons, record NCT01335867-844973e2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01335867-844973e2
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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 | 0.194 | wilson | |
| Risk in group 2 | 0.125 | 0.035 | 0.36 | wilson | |
| Risk difference, group 1 minus group 2 | -0.125 | -0.36 | 0.0885 | 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 fewer participant with the outcome on Vigabatrin than on Placebo | 8 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vigabatrin | Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks | 0 | 16 | OG000 |
| Group 2 | Placebo | Placebo: Placebo pills | 2 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With a Reduction in Cocaine Use
- Description
The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.
- Time frame
- last 3 weeks of the trial
- Population
Source ClinicalTrials.gov
Trial
- Title
- Vigabatrin for Cocaine and Alcohol Dependence
- NCT number
- NCT01335867
- Phases
- PHASE2
- Conditions
- Alcoholism, Cocaine Dependence
- Interventions
- Vigabatrin, Placebo
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2015-06-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01335867?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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