Kudzu Treatment for Alcohol Abuse

Alcohol Consumption Clinical Trial

— KUDZU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596231
• Other study ID #: 2010-P-001099
• Secondary ID: Grant # AA10536
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2012
• Last updated: October 15, 2014
• Start date: May 2010
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking

Intervention

Dietary Supplement:
• Kudzu
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.
• Placebo
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Study end	No

External Links

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