Comparison · NCT02252536-43b05cd3
Sugar Pill vs Gabapentin Enacarbil: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels
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. Sugar Pill vs Gabapentin Enacarbil: Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels. Trial comparisons, record NCT02252536-43b05cd3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02252536-43b05cd3
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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 | 0.515 | 0.431 | 0.598 | wilson | |
| Risk in group 2 | 0.548 | 0.467 | 0.626 | wilson | |
| Risk difference, group 1 minus group 2 | -0.033 | -0.148 | 0.0829 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.94 | 0.754 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.876 | 0.547 | 1.4 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sugar Pill than on Gabapentin Enacarbil | 30.3 | 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 | Sugar Pill | Matching placebo, sugar pill~Placebo: Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day | 69 | 134 | OG000 |
| Group 2 | Gabapentin Enacarbil | 600 mg Gabapentin Enacarbil (Horizant)~gabapentin enacarbil: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day | 80 | 146 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels
- Description
Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows:~Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g
- Time frame
- Weeks 22-25
- Population
Source ClinicalTrials.gov
Trial
- Title
- HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
- NCT number
- NCT02252536
- Phases
- PHASE2
- Conditions
- Alcohol Use Disorder
- Interventions
- gabapentin enacarbil, Placebo
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Results first posted
- 2018-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02252536?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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