Comparison · NCT00502216-2c2ea68c
Varenicline + Naltrexone vs Varenicline + Placebo: Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline
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. Varenicline + Naltrexone vs Varenicline + Placebo: Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline. Trial comparisons, record NCT00502216-2c2ea68c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00502216-2c2ea68c
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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 | 0.476 | 0.283 | 0.676 | wilson | |
| Risk in group 2 | 0.211 | 0.0851 | 0.433 | wilson | |
| Risk difference, group 1 minus group 2 | 0.266 | -0.029 | 0.502 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.26 | 0.849 | 6.02 | log | |
| Odds ratio, group 1 over group 2 | 3.41 | 0.844 | 13.8 | log | |
| Number needed to treat, for one more participant with the outcome on Varenicline + Naltrexone than on Varenicline + Placebo | 3.76 | 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 | Varenicline + Naltrexone | Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day | 10 | 21 | OG000 |
| Group 2 | Varenicline + Placebo | Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day | 4 | 19 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline
- Description
Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event.
- Time frame
- 11 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers
- NCT number
- NCT00502216
- Phases
- PHASE1, PHASE2
- Conditions
- Smoking, Nicotine Dependence
- Interventions
- Naltrexone, Varenicline
- Lead sponsor
- Yale University
- Results first posted
- 2010-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00502216?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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