Trial · NCT01764685
Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
NCT01764685, Phase 2, Terminated, University of Pennsylvania; results first posted 2016-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers. Trials, record NCT01764685. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01764685
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
- NCT number
- NCT01764685
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Heavy Drinking, HIV, Alcohol Dependence
- Interventions
- Topiramate, Medical Management, Placebo
- First posted
- 2013-01-09
- Last updated
- 2016-03-15
- Results first posted
- 2016-02-17
- Limitations and caveats
We closed our enrollment before meeting recruitment goals, due to difficulties with recruitment. We didn't analyze our data, due to a sample size of 4, that were all randomized to placebo group and only 3 of the 4 completed the study procedures.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Heavy Drinking Days Per Week by Medication Group | 11-week study period | Total number of heavy drinking days (\>4 drinks for men; \>3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Heavy Drinking Days Per Week by Medication Group | 11-week study period | Data was only collected on 3 of the 4 subjects. | Number of heavy drinking days/week | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Heavy Drinking Days Per Week by Medication Group | Placebo Pill + Medical Management | 2 | Number of heavy drinking days/week |
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 + Medical Management | 0 | |
| Overall Study | STARTED | Placebo Pill + Medical Management | 4 | |
| Overall Study | COMPLETED | Topiramate + Medical Management | 0 | |
| Overall Study | COMPLETED | Placebo Pill + Medical Management | 3 | |
| Overall Study | NOT COMPLETED | Topiramate + Medical Management | 0 | |
| Overall Study | NOT COMPLETED | Placebo Pill + Medical Management | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | Increase in viral load from start to end of study | Immune system disorders | Topiramate + Medical Management | 0 | 0 | 0 |
| other | Increase in viral load from start to end of study | Immune system disorders | Placebo Pill + Medical Management | 2 | 4 | 2 |
| other | Hematuria | Renal and urinary disorders | Topiramate + Medical Management | 0 | 0 | 0 |
| other | Hematuria | Renal and urinary disorders | Placebo Pill + Medical Management | 1 | 4 | 1 |
| other | Decrease in viral load from start to end of study | Immune system disorders | Topiramate + Medical Management | 0 | 0 | 0 |
| other | Decrease in viral load from start to end of study | Immune system disorders | Placebo Pill + Medical Management | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Topiramate + Medical Management | ||
| Total, all-cause mortality | Placebo Pill + Medical Management | ||
| Total, other adverse events | Topiramate + Medical Management | 0 | 0 |
| Total, other adverse events | Placebo Pill + Medical Management | 2 | 4 |
| Total, serious adverse events | Topiramate + Medical Management | 0 | 0 |
| Total, serious adverse events | Placebo Pill + Medical Management | 0 | 4 |
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.
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/NCT01764685
GET https://conductscience.org/api/trials/v1/NCT01764685/registered