This is a competing renewal of our application in response to Program Announcement PA-05-097, Complementary and Alternative Medicine for Substance- and Alcohol-Related Disorders. There are no uniformly effective pharmacotherapies for treating alcohol abuse/dependence, but there are some promising agents that continue to evolve. However, some are not yet FDA approved, others are available only by prescription and most have adverse side effects that would limit their usefulness in pregnant women and adolescents. Thus, a completely safe and effective medication for reducing alcohol intake remains unavailable. During the previous award period we have made substantial progress in exploring the safety and efficacy of an isoflavone preparation from Pueraria lobata, the kudzu plant. Specifically, we have made progress on all specific aims including the following: 1) We have solved the problem of purity of the preparation and have prepared an extract that contains a higher (and precise) concentration of the active isoflavones found in the original plant. 2) We have developed methods for monitoring compliance and bioavailability of the kudzu preparation. 3) We have given kudzu extract to nearly 200 persons and the extensive safety data collected indicates that it has no side effects. 4) We have published or submitted papers showing that kudzu does, in fact, reduce alcohol drinking by heavy drinkers in both a simulated natural setting and in an outpatient clinical trial. 5) We have collected preliminary data showing that kudzu increases the rate.
