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Kudzu Treatment for Alcohol Abuse (KUDZU)

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Kudzu
Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption focused on measuring Alcohol consumption, Kudzu extract

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Kudzu

Arm Description

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 2mg

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 9, 2012
Last Updated
October 15, 2014
Sponsor
Mclean Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01596231
Brief Title
Kudzu Treatment for Alcohol Abuse
Acronym
KUDZU
Official Title
Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption
Keywords
Alcohol consumption, Kudzu extract

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Kudzu
Arm Type
Active Comparator
Arm Description
Kudzu 2mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Kudzu
Other Intervention Name(s)
Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Primary Outcome Measure Information:
Title
Drinking Behaviors
Description
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).
Time Frame
Study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott E. Lukas, Ph.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26048637
Citation
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.
Results Reference
derived

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Kudzu Treatment for Alcohol Abuse

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