Trial · NCT00329407
The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
NCT00329407, Phase 4, Completed, Boston University; results first posted 2010-08-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects. Trials, record NCT00329407. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00329407
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects
- NCT number
- NCT00329407
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 10 participants, actual
- Lead sponsor
- Boston University
- Conditions
- Alcoholism
- Interventions
- Topiramate (Topamax)
- First posted
- 2006-05-24
- Last updated
- 2010-09-08
- Results first posted
- 2010-08-04
- Limitations and caveats
Limitation of this trial include the small number of subjects included and lack of blinding, and inculsion of a placebo control group. An other limitation was the testing the active medication topiramate at om=nly one dose level (i.e. 400 mg daily).
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method | 70 days | The primary outcome was the mean daily consumption of standard alcoholic drinks (14 g per ethanol) during the baseline week compared to week 10, the final week subjects were one maintenance dose of topirmate. |
| Secondary | Phonetic Portion of the Controlled Word Association Test (COWAT) | Baseline compared to Week 10 | Phonetic COWAT is a measure of verbal fluency. Results are in terms of number of words produced starting with a set of particular letters.This involves a comparison of baseline and Week 10 COWAT scores |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method | 70 days | An ITT approach was used in the analysis. Least squares value for the baseline and 10 week of treatment were compared using a t test with Dunnett-Hsu adjustment. Differences between these means are presented as the result. | Standard Drink (14 g alcohol) | MEAN |
| SECONDARY | Phonetic Portion of the Controlled Word Association Test (COWAT) | Baseline compared to Week 10 | Number of words | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Outcome Measure Will be Subjects Ethanol Consumption Over the Course of the Drug Treatment Period as Assessed by the Timeline Followback Method | Topiramate Treatment | -4.9 | Standard Error 0.86 | Standard Drink (14 g alcohol) | |
| Phonetic Portion of the Controlled Word Association Test (COWAT) | Topiramate Treatment | -11 | Standard Error 2.7 | Number of words |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Topiramate Treatment | 10 | |
| Overall Study | COMPLETED | Topiramate Treatment | 9 | |
| Overall Study | NOT COMPLETED | Topiramate Treatment | 1 |
Source ClinicalTrials.gov
Adverse events1
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 | Agitation and Impaired Concentration | Nervous system disorders | Topiramate Treatment | 2 | 10 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate Treatment | ||
| Total, other adverse events | Topiramate Treatment | 2 | 10 |
| Total, serious adverse events | Topiramate Treatment | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Fluency | Secondary outcome |
Source ConductCognition
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/NCT00329407
GET https://conductscience.org/api/trials/v1/NCT00329407/registered