Trial · NCT00862563
Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
NCT00862563, Phase 2, Terminated, Boston Medical Center; results first posted 2015-04-07
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ConductScience Library. Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism. Trials, record NCT00862563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862563
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
- NCT number
- NCT00862563
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Boston Medical Center
- Conditions
- Alcoholism, Alcohol Dependence, Alcohol Abuse
- Interventions
- Topiramate, Zonisamide, Levetiracetam, Sugar Pill
- First posted
- 2009-03-17
- Last updated
- 2015-04-28
- Results first posted
- 2015-04-07
- Limitations and caveats
- Early termination lead to a small number of subjects in each group being analyzed.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Weeks 10, 11, 12 | Mean standard drinks consumed per day for each treatment week, weeks 10 thru 12. Actual mean values obtained are shown. Analyses are based on model generated least squares means for a two -way repeated measures mixed models analysis for data obtained for weeks 1 through 12, with baseline values used as covariates. Week (time) was used as the within subject factor and treatment group was the between group factor. |
| Secondary | AB-Neurotoxicity Scale. | Week 12 | Total Scores AB-Neurotoxicity Scale Week 12. This scale provides subject ratings of anticonvulsant neurotoxic effects. Scores may range 0 to 72, with possibility of an additional 30 points being for complaints not listed in the list of complaints provides. Total scores, therefore, may be as high as 102, with higher scores indicating greater severity of problems. Actual mean scores are shown. Means for the analysis are least means squares values obtained from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. |
| Secondary | Mean Percent Days Heavy Drinking | Weeks 10, 11, 12 | Mean weekly values for each treatment group for percent days heavy drinking. Heavy drinking was defined as 4 or more drinks per day for women and 5 or more drinks per day for men. |
| Secondary | Percent Days Drinking | Weeks 10, 11, 12 | Mean percent days drinking for Weeks 10, 11, 12. A drinking day is considered to be a day in which 1 or more drinks have been consumed. Means are model generated least means squares values obtained from a two-way repeated measures analysis from data obtained from Weeks 1 through 12, with Week as the within subject factor and treatment group as the between group factor. |
| Secondary | Controlled Word Association Test (COWAT)- Letter Fluency | Baseline & Week 12 | Number of words generated that start with a set of 3 letters. The COWAT provides a measure of verbal fluency. Actual means for COWAT results are shown. |
| Secondary | COWAT-Category | Baseline, Week12 | Number of words produced by subjects over 60 seconds for a semantic category (Animals). The COAWAT-Category sub-test provides a measure of verbal fluency. Mean value shown are actual means for the number of words produced. |
| Secondary | Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total | Baseline, Week 12 | WMS Digit Span is a measure of working memory. Subjects respond by repeating lists of number sequences presented by the test administrator. Age adjusted scores are presented below. Scores may range between 1 and 19, with lower scores indicating poorer performance on the task. |
| Secondary | Wechsler Memory Scale-3rd Ed. Spatial Span | Baseline, Week 12 | WMS Spatial Span test measures working memory for a spatial sequence of numbers. This assesses visual working memory. Age adjusted scaled scores are presented. Score may range between 1 and 19, with lower scores indicating greater impairment in performance. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Weeks 10, 11, 12 | Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12. | Standard Drinks per day | MEAN |
| SECONDARY | AB-Neurotoxicity Scale. | Week 12 | Alcohol dependent subjects. | Scale Scores | MEAN |
| SECONDARY | Mean Percent Days Heavy Drinking | Weeks 10, 11, 12 | Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the time frame for the specific analyses, i.e. Weeks 10,11,12. | Percentage of Days/Week | MEAN |
| SECONDARY | Percent Days Drinking | Weeks 10, 11, 12 | Alcohol dependent subjects. Alcohol dependent subjects. Number of participants analyzed are provided for the number of subjects for data that was available for the timeframe for the specific analyses, i.e. Weeks 10,11,12. | Percentage of Days/ Week | MEAN |
| SECONDARY | Controlled Word Association Test (COWAT)- Letter Fluency | Baseline & Week 12 | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Number of Words Produced | MEAN |
| SECONDARY | COWAT-Category | Baseline, Week12 | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | Number of Words Produced | MEAN |
| SECONDARY | Wechsler Memory Scales (WMS)-3d Ed Digit Span-Age Adjusted Total | Baseline, Week 12 | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | units on a scale | MEAN |
| SECONDARY | Wechsler Memory Scale-3rd Ed. Spatial Span | Baseline, Week 12 | Alcohol Dependent Subjects. Number of participants analyzed represent the number for whom Week 12 data was available. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Zonisamide | Week 10 | 3.8 | Standard Error 0.9 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Sugar Pill | Week 10 | 6.3 | Standard Error 0.9 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Topiramate | Week 10 | 3.2 | Standard Error 0.8 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Levetiracetam | Week 10 | 4.6 | Standard Error 0.8 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Zonisamide | Week 11 | 3.4 | Standard Error 0.6 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Sugar Pill | Week 11 | 6.8 | Standard Error 1.2 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Topiramate | Week 11 | 2.7 | Standard Error 0.7 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Levetiracetam | Week 11 | 4.3 | Standard Error 0.7 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Zonisamide | Week 12 | 2.5 | Standard Error 0.7 | Standard Drinks per day |
The Primary Efficacy Measure is the Mean Number of Drinks Consumed Per Day Over the Period From Treatment Weeks 10 Through 12 When All Study Medications Should be at Their Maximum Steady Levels Based on Their Known Pharmacokinetic Properties. | Sugar Pill | Week 12 | 6.0 | Standard Error 0.9 | Standard Drinks per day |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zonisamide | 19 | |
| Overall Study | STARTED | Levetiracetam | 21 | |
| Overall Study | STARTED | Topiramate | 21 | |
| Overall Study | STARTED | Sugar Pill | 24 | |
| Overall Study | COMPLETED | Zonisamide | 15 | |
| Overall Study | COMPLETED | Levetiracetam | 17 | |
| Overall Study | COMPLETED | Topiramate | 15 | |
| Overall Study | COMPLETED | Sugar Pill | 19 | |
| Overall Study | NOT COMPLETED | Zonisamide | 4 | |
| Overall Study | NOT COMPLETED | Levetiracetam | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events116
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 | Anxiety | Psychiatric disorders | Zonisamide | 3 | 19 | 3 |
| other | Anxiety | Psychiatric disorders | Levetiracetam | 2 | 21 | 2 |
| other | Anxiety | Psychiatric disorders | Topiramate | 3 | 21 | 3 |
| other | Anxiety | Psychiatric disorders | Sugar Pill | 2 | 24 | 2 |
| other | Altered Taste | General disorders | Zonisamide | 2 | 19 | 2 |
| other | Altered Taste | General disorders | Levetiracetam | 0 | 21 | 0 |
| other | Altered Taste | General disorders | Topiramate | 0 | 21 | 0 |
| other | Altered Taste | General disorders | Sugar Pill | 0 | 24 | 0 |
| other | Confusion | Nervous system disorders | Zonisamide | 0 | 19 | 0 |
| other | Confusion | Nervous system disorders | Levetiracetam | 0 | 21 | 0 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zonisamide | ||
| Total, all-cause mortality | Levetiracetam | ||
| Total, all-cause mortality | Topiramate | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Zonisamide | 15 | 19 |
| Total, other adverse events | Levetiracetam | 11 | 21 |
| Total, other adverse events | Topiramate | 13 | 21 |
| Total, other adverse events | Sugar Pill | 11 | 24 |
| Total, serious adverse events | Zonisamide | 1 | 19 |
| Total, serious adverse events | Levetiracetam | 0 | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25427171 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| R01AA015923 | Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism | FARCHIONE, TODD J. | BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2009 to 2020 | NIH RePORTER |
| P60AA013759 | Center to Prevent Alcohol Problems Among Young People | ROSENBLOOM, DAVID L | BOSTON UNIVERSITY MEDICAL CAMPUS | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2004 to 2009 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
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 | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | 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
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The record and each of its lists are JSON, twenty rows a page. No key.
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