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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cannabis Use | Weeks 1-6 | Frequency of Cannabis Use (Percent Use Days Per Week) |
| Secondary | Quantity of Cannabis Use | Weeks 1-6 | Total Grams of Cannabis Use Per week |
| Secondary | Amount of Cannabis Use Per Use Day | Weeks 1-6 | Average Grams of Cannabis Used Per Use Day |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cannabis Use | Weeks 1-6 | Percentage of use days | MEAN | |
| SECONDARY | Quantity of Cannabis Use | Weeks 1-6 | Grams Per Week | MEAN | |
| SECONDARY | Amount of Cannabis Use Per Use Day | Weeks 1-6 | Average Grams Per Use Day | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cannabis Use | Topiramate | 55.89 | Standard Deviation 32.35 | Percentage of use days | |
| Cannabis Use | Sugar Pill | 63.10 | Standard Deviation 34.91 | Percentage of use days | |
| Quantity of Cannabis Use | Topiramate | 1.87 | Standard Deviation 2.11 | Grams Per Week | |
| Quantity of Cannabis Use | Sugar Pill | 2.85 | Standard Deviation 3.29 | Grams Per Week | |
| Amount of Cannabis Use Per Use Day | Topiramate | 0.46 | Standard Deviation 0.32 | Average Grams Per Use Day | |
| Amount of Cannabis Use Per Use Day | Sugar Pill | 0.60 | Standard Deviation 0.48 | Average Grams Per Use Day |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate | 40 | |
| Overall Study | STARTED | Sugar Pill | 26 | |
| Overall Study | COMPLETED | Topiramate | 29 | |
| Overall Study | COMPLETED | Sugar Pill | 20 | |
| Overall Study | NOT COMPLETED | Topiramate | 11 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 6 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Topiramate | 8 | 40 | |
| other | Headache | General disorders | Sugar Pill | 6 | 26 | |
| other | Rash | Skin and subcutaneous tissue disorders | Topiramate | 0 | 40 | |
| other | Rash | Skin and subcutaneous tissue disorders | Sugar Pill | 3 | 26 | |
| other | Cough, Cold Symptoms | General disorders | Topiramate | 5 | 40 | |
| other | Cough, Cold Symptoms | General disorders | Sugar Pill | 5 | 26 | |
| other | Injury | General disorders | Topiramate | 8 | 40 | |
| other | Injury | General disorders | Sugar Pill | 5 | 26 | |
| other | Parasthesias | General disorders | Topiramate | 15 | 40 | |
| other | Parasthesias | General disorders | Sugar Pill | 2 | 26 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate | 0 | 40 |
| Total, all-cause mortality | Sugar Pill | 0 | 26 |
| Total, other adverse events | Topiramate | 35 | 40 |
| Total, other adverse events | Sugar Pill | 24 | 26 |
| Total, serious adverse events | Topiramate | 0 | 40 |
| Total, serious adverse events | Sugar Pill | 0 | 26 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DA026778 | Biobehavioral effects of topiramate on cannabis-related outcomes in adolescents | MIRANDA, ROBERT | BROWN UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2009 to 2010 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate vs Sugar Pill: deaths from any cause | Trial comparisons |
| Topiramate vs Sugar Pill: serious adverse events | Trial 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.
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