Kudzu Treatment for Alcohol Abuse

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Consumption

In brief

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.

Key facts

Study ID

NCT01596231

Run by

Mclean Hospital

People needed

20

Starts

2010-05-01

Expected to finish

2014-07-01

Last updated by the study team

2014-10-21

Who can join

Age: 21 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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