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Completed

NCT Number: NCT01596231

Kudzu Treatment for Alcohol Abuse

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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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kudzu

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.

Other names: Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®

Placebo

Dietary Supplement

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

Primary outcomes

  1. Drinking Behaviors

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: KUDZU

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 10, 2012
Registry last updated
Oct 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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