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 |
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.
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.
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
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