drugset / Trial / NCT03479086
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
Phase 3
Unknown
180 enrolled
South West Sydney Local Health District
National Health and Medical Research Council, Australia · collabUniversity of Sydney · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.
Timeline
- Start
- 2017-06-20
- Primary completion
- 2020-11-01
- Completion
- 2020-11-01
Publications
- Logge WB, Haber PS, Hurzeler T, Gallagher H, Kranzler H, Morley KC. Neural cue reactivity and intrinsic functional connectivity in individuals with alcohol use disorder following treatment with topiramate or naltrexone. Psychopharmacology (Berl). 2025 Jul;242(7):1641-1652. doi: 10.1007/s00213-025-06745-7. Epub 2025 Jan 24.
- Morley KC, Kranzler HR, Luquin N, Baillie A, Shanahan M, Trent R, Teesson M, Haber PS. Topiramate versus naltrexone for alcohol use disorder: study protocol for a genotype-stratified, double-blind randomised controlled trial (TOP study). Trials. 2018 Aug 16;19(1):443. doi: 10.1186/s13063-018-2824-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 50 mg | — |
| Subject | Topiramate | Small molecule | 200 mg | — |