This study will evaluate the efficacy of targeted dosing of kudzu among binge drinking individuals with alcohol use disorders (AUD). Binge drinking (defined as drinking five or more drinks on one occasion for men, and four or more drinks for women), is highly prevalent in the US. Binge drinking accounts for more than half of the 80,000 annual deaths attributed to excessive alcohol consumption and its economic costs exceeds $191 billion in the US. National HIV Behavioral Surveillance data indicate that 48% of heterosexual men, 58% of men who have sex with men, and 40% of heterosexual women reported binge drinking (past 30 days). Binge drinking has been independently associated with condomless sex and HIV infection. Binge drinking is by far the most prevalent exposure linked to HIV infections. Thus, effective interventions to reduce binge drinking may function as an important HIV prevention intervention by reducing alcohol-related sexual risk behaviors. Kudzu may be a promising treatment for binge drinking that has been used for medicinal purposes to treat alcohol abuse in East Asia since 600 AD. Kudzu contain isoflavones that have been consistently shown to suppress alcohol use in all animal studies conducted to date. Among humans, kudzu was associated with significant reductions in number of drinks consumed, volume of alcohol per sip and slower rate in drinking compared to placebo. In a double- blind, randomized, placebo-controlled trial, kudzu significantly reduced the number of drinks consumed, reduced the number of heavy drinking days, and significantly increased the percent of days abstinent during a 4-week follow-up. Kudzu?s pharmacokinetic properties and rapid onset of action support targeted administration (i.e., use in anticipation of heavy alcohol use on an ?as-needed? basis). Kudzu can reach peak plasma levels within 2 hours of oral administration and has a mean elimination half-life of 4.3 hours. A single dose of kudzu administered before drinking has been associated with significant reductions in number of drinks and slower rate of drinking, compared to placebo, providing evidence that kudzu can be taken on an as-needed basis. Despite the mounting evidence of kudzu?s effects on alcohol, there have been no efficacy studies evaluating targeted kudzu among binge-drinkers and no trials aimed at reducing alcohol-associated risk behaviors. Study Design: This is a double-blind, placebo-controlled trial of 120 binge-drinkers with AUD to 12 weeks of kudzu (2g), to be taken in anticipation of heavy drinking. Participants will be seen weekly for alcohol-metabolite urine testing, study drug dispensing, and brief counseling for alcohol use. Safety assessments and behavioral surveys will be completed monthly. Efficacy on alcohol use and alcohol-associated sexual risk behaviors (Aims 1-3) will be assessed using weekly time-line follow-back, screening for ethyl glucuronide (EtG)-positive urines, and computer-administered monthly interviews. Sexually transmitted infection testing will occur at baseline and month 3 visits (Aim 3). Tolerability and acceptability (Aim 4) will be assessed through tracking of adverse events and medication adherence. Durability of treatment will be assessed at 1- and 3-month post-treatment visits.
Drinking multiple alcoholic drinks on a single occasion (binge drinking), has many negative health risks but interventions to address this behavior remain limited. This double-blind, placebo-controlled randomized clinical trial will test whether kudzu, an herbal supplement, can reduce heavy alcohol use and alcohol-associated sexual behaviors among sexually-active, binge-drinking individuals at high risk for HIV infection.
