Kudzu Treatment for Alcohol Abuse

Study Overview
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Brief Summary
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This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.

Detailed Description
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In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.

Official Title
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Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study

Conditions
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Alcohol Consumption

Intervention / Treatment
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* Dietary Supplement: Kudzu
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of understanding and complying with the protocol Good physical and mental health (normal physical exam, ECG, blood and urine chemistries) Body Mass Index between 18-30, inclusive Age 21-40 years Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting) Have a stable living situation with current postal address Exclusion Criteria: Concurrent diagnosis of Axis I disorder Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years. Immediate family history pattern of alcoholism or problem drinking (parents or siblings) Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable. Subjects cannot be actively seeking treatment for any drug or alcohol dependence. Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met. Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions. Tobacco use greater than 5 cigarettes per day History of major head trauma resulting in cognitive impairment or history of seizure disorder Heavy caffeine use (greater than 500 mg on a regular, daily basis) Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal For female volunteers, a positive pregnancy test

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session. | Dietary Supplement: Placebo<br>* Placebo will be administered as a pretreatment 2 ½ hours before a drinking session<br>|
| Active Comparator: Kudzu<br>Kudzu 2mg | Dietary Supplement: Kudzu<br>* Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.<br>* Other names: Alkontrol-Herbal®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking Behaviors | A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks). | Study end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol consumption, Kudzu extract