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Trial · NCT01110434

Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

NCT01110434, Phase 2, Completed, Brown University; results first posted 2020-09-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents. Trials, record NCT01110434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01110434

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents
NCT number
NCT01110434
Status
Completed
Phases
Phase 2
Enrollment
66 participants, actual
Lead sponsor
Brown University
Conditions
Cannabis Abuse, Cannabis Dependence
Interventions
Topiramate, Placebo
First posted
2010-04-26
Last updated
2020-09-16
Results first posted
2020-09-16

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCannabis UseWeeks 1-6Frequency of Cannabis Use (Percent Use Days Per Week)
SecondaryQuantity of Cannabis UseWeeks 1-6Total Grams of Cannabis Use Per week
SecondaryAmount of Cannabis Use Per Use DayWeeks 1-6Average Grams of Cannabis Used Per Use Day

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYCannabis UseWeeks 1-6Percentage of use daysMEAN
SECONDARYQuantity of Cannabis UseWeeks 1-6Grams Per WeekMEAN
SECONDARYAmount of Cannabis Use Per Use DayWeeks 1-6Average Grams Per Use DayMEAN

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Cannabis UseTopiramate55.89Standard Deviation 32.35Percentage of use days
Cannabis UseSugar Pill63.10Standard Deviation 34.91Percentage of use days
Quantity of Cannabis UseTopiramate1.87Standard Deviation 2.11Grams Per Week
Quantity of Cannabis UseSugar Pill2.85Standard Deviation 3.29Grams Per Week
Amount of Cannabis Use Per Use DayTopiramate0.46Standard Deviation 0.32Average Grams Per Use Day
Amount of Cannabis Use Per Use DaySugar Pill0.60Standard Deviation 0.48Average Grams Per Use Day

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDTopiramate40
Overall StudySTARTEDSugar Pill26
Overall StudyCOMPLETEDTopiramate29
Overall StudyCOMPLETEDSugar Pill20
Overall StudyNOT COMPLETEDTopiramate11
Overall StudyNOT COMPLETEDSugar Pill6

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHeadacheGeneral disordersTopiramate840
otherHeadacheGeneral disordersSugar Pill626
otherRashSkin and subcutaneous tissue disordersTopiramate040
otherRashSkin and subcutaneous tissue disordersSugar Pill326
otherCough, Cold SymptomsGeneral disordersTopiramate540
otherCough, Cold SymptomsGeneral disordersSugar Pill526
otherInjuryGeneral disordersTopiramate840
otherInjuryGeneral disordersSugar Pill526
otherParasthesiasGeneral disordersTopiramate1540
otherParasthesiasGeneral disordersSugar Pill226

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityTopiramate040
Total, all-cause mortalitySugar Pill026
Total, other adverse eventsTopiramate3540
Total, other adverse eventsSugar Pill2426
Total, serious adverse eventsTopiramate040
Total, serious adverse eventsSugar Pill026

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
29672090DERIVEDPubMed
34014688DERIVEDPubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
R01DA026778Biobehavioral effects of topiramate on cannabis-related outcomes in adolescentsMIRANDA, ROBERTBROWN UNIVERSITYNATIONAL INSTITUTE ON DRUG ABUSE2009 to 2010

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Topiramate vs Sugar Pill: deaths from any causeTrial comparisons
Topiramate vs Sugar Pill: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01110434

GET https://conductscience.org/api/trials/v1/NCT01110434/events?page=2