Trial · NCT03479086
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
NCT03479086, Phase 3, Unknown, South West Sydney Local Health District
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia. Trials, record NCT03479086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03479086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
- NCT number
- NCT03479086
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 180 participants, estimated
- Lead sponsor
- South West Sydney Local Health District
- Conditions
- Alcohol Dependence
- Interventions
- Topiramate, Naltrexone
- First posted
- 2018-03-27
- Last updated
- 2018-05-11
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of heavy drinking days, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with Phosphatidylethanol (PEth) levels |
| Primary | Time to relapse, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Time to lapse, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Number of days abstinent, as measured by the Time Line Follow Back | Over 12 weeks | Corroborated with PEth levels |
| Primary | Number of standard drinks per drinking day, as measured by the Time Line Follow Back | 12 weeks | Corroborated with PEth levels |
| Secondary | Self report of adverse events | 12 weeks | as reported by patient during weekly medical management sessions facilitated by the treating doctor. |
| Secondary | Penn Alcohol Craving Scale for alcohol craving | 12 weeks | as measured by amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol. |
| Secondary | DASS21 score for presence and/or severity of anxiety | 12 weeks | as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21). |
| Secondary | DASS21 score for presence and/or severity of depression | 12 weeks | as measured by cumulative score for depression related questions |
| Secondary | Insomnia Severity Index for sleep disturbances | 12 weeks | as measured by cumulative score of satisfaction with current sleep patterns and extent to which sleep disturbances interfere and impair with every day activities and daily functioning |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03479086
GET https://conductscience.org/api/trials/v1/NCT03479086/registered