Kudzu Treatment for Alcohol Abuse

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Alcohol Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Kudzu

Kudzu 2mg

Group Type ACTIVE_COMPARATOR

Kudzu

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Kudzu

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Kudzu root extract (NPI-031) Puerariae lobata Alkontrol-Herbal®

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes