Kudzu Treatment for Alcohol Abuse (KUDZU)

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Kudzu

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: Placebo; Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Active Comparator: Kudzu; Kudzu 2mg	Dietary supplement: 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.; Other Names: Kudzu root extract (NPI-031); Puerariae lobata; Alkontrol-Herbal®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mclean Hospital
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Scott E. Lukas, Ph.D., McLean Hospital

Publications and helpful links

General Publications

• Penetar DM, Toto LH, Lee DY, Lukas SE. A single dose of kudzu extract reduces alcohol consumption in a binge drinking paradigm. Drug Alcohol Depend. 2015 Aug 1;153:194-200. doi: 10.1016/j.drugalcdep.2015.05.025. Epub 2015 May 27.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Alcohol consumption; Kudzu extract
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 2010-P-001099; Grant # AA10536 (Other Grant/Funding Number: NIAAA)