Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
Summary
This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alcohol consumption level to determine basic eligibility by telephone, or in person. Individuals who meet telephone screening criteria will be scheduled for a clinic appointment to obtain informed consent and conduct screening assessments. Subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two weeks prior to screening will be excluded. Subjects meeting screening criteria will be scheduled for a second randomization visit. During this visit baseline assessments will be obtained. Eligible subjects will then be randomized to a treatment group and will be provided with the first week's study medications. The goal is to directly compare the efficacy and tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a positive control group. We believe that this will be the first direct comparison of these agents in alcoholism, and the results will provide information on the efficacy and safety of the medications.
Timeline
- Start
- 2009-05
- Primary completion
- 2013-08
- Completion
- 2013-08
Outcome
Met primary endpoint
Stopped (Enrollment): “Recruitment goals could not be met before ending of funding for this project.”
registry analysis (superiority or other test); Zonisamide vs Sugar Pill; p = 0.008; Difference between least squares means -3.0; ANOVA NCT00862563 ↗
paper Compared with placebo, both zonisamide and topiramate produced significant reductions in the drinks consumed per day PMID 25427171 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levetiracetam | Other / unclassified | 2000 mg | Oral |
| Comparator | Topiramate | Small molecule | 300 mg | Oral |
| Subject | Zonisamide | Other / unclassified | 400 mg | Oral |