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Comparison · NCT01811940-37faa16d

Adderall-ER and Topiramate vs Placebo: Any Three Consecutive Weeks of Abstinence During Study

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. Adderall-ER and Topiramate vs Placebo: Any Three Consecutive Weeks of Abstinence During Study. Trial comparisons, record NCT01811940-37faa16d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01811940-37faa16d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2190.1350.334wilson
Risk in group 20.06350.0250.152wilson
Risk difference, group 1 minus group 20.1550.03330.277newcombe hybrid score
Risk ratio, group 1 over group 23.451.29.9log
Odds ratio, group 1 over group 24.131.2813.4log
Number needed to treat, for one more participant with the outcome on Adderall-ER and Topiramate than on Placebo6.443.6130from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Adderall-ER and Topiramate
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.~Adderall-ER: MAS-ER 60mg/day~Topiramate: Topiramate 100 mg bid.
1464OG000
Group 2Placebo
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.~Placebo: Placebo
463OG001

Outcome

Type
SECONDARY
Title
Any Three Consecutive Weeks of Abstinence During Study
Description
The proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week.
Time frame
14 weeks of study or length of study participation
Population

Source ClinicalTrials.gov

Trial

Title
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
NCT number
NCT01811940
Phases
PHASE2, PHASE3
Conditions
Cocaine Dependence
Interventions
Adderall-ER, Topiramate, Placebo
Lead sponsor
New York State Psychiatric Institute
Results first posted
2018-10-12

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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