Title: Effectiveness of Zonisamide in the Treatment of Alcohol-Dependent Veterans ABSTRACT: Veterans have a high prevalence of alcohol dependence (AD), and those with AD also have a high rate of co-occurring psychiatric illnesses. Zonisamide is an extremely promising medicine for treating AD and managing other clinical problems including psychiatric disorders. Zonisamide is an affordable, generic anticonvulsant with unique actions on the major neurotransmitter systems involved in alcoholism, and it has neuroprotective effects. We recently completed a randomized, placebo- controlled pilot study of zonisamide in treating AD that showed significant reductions in heavy drinking, overall drinking, and alcohol craving. Zonisamide was very well tolerated in this study. In this application, we propose a larger (N = 160), 14-week, randomized, double-blind, placebo-controlled, effectiveness study of zonisamide in reducing heavy drinking and improving outcomes in a representative population of heavy-drinking veterans with AD. We describe zonisamide's potential to break through the barriers in the treatment of veterans with AD as well as its unique pharmacology that brings innovation to alcoholism treatment. An inexpensive, hypothesis-driven, exploratory, translational, pharmacogenetic component adds to the innovation and will work towards optimizing outcomes and personalizing treatment for veterans.

Public Health Relevance

Alcohol dependence continues to have a tremendous impact on veterans, and there is a great need for new treatments that supersede the limitations of those currently available. The proposed clinical effectiveness trial will evaluate the usefulness of zonisamide, a medication that appears likely to realize the goal of breaking the boundaries of current treatments, for treating alcohol-dependent veterans.

Agency
National Institute of Health (NIH)
Institute
Veterans Affairs (VA)
Type
Non-HHS Research Projects (I01)
Project #
5I01CX001012-02
Application #
9205176
Study Section
Clinical Trials - A (CLNA)
Project Start
2015-10-01
Project End
2020-09-30
Budget Start
2016-10-01
Budget End
2017-09-30
Support Year
2
Fiscal Year
2017
Total Cost
Indirect Cost
Name
VA Connecticut Healthcare System
Department
Type
DUNS #
039624291
City
West Haven
State
CT
Country
United States
Zip Code
06516