Kudzu Treatment for Alcohol Abuse

Phase 2

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Kudzu	Kudzu	Kudzu 2mg

Primary Outcome Measures

Name	Time	Method
Drinking Behaviors	Study end	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).

Secondary Outcome Measures