Kudzu Treatment for Alcohol Abuse



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:21 - 40
Updated:11/8/2014
Start Date:May 2010
Contact:Lindsay Toto, BA
Email:ltoto@mclean.harvard.edu
Phone:617-855-2419

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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.

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.

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
We found this trial at
1
site
115 Mill St
Belmont, Massachusetts 02478
(617) 855-2000
McLean Hospital McLean Hospital is a comprehensive psychiatric hospital committed to providing easy access to...
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mi
from
Belmont, MA
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