Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Study Overview
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Brief Summary
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This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).

Official Title
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Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Conditions
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Alcohol Consumption, Cerebral Blood Flow

Intervention / Treatment
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* Dietary Supplement: Kudzu extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of understanding and complying with the protocol Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, no psychopathologies) Body Mass Index between 18-30, inclusive Age 21-40 years Moderate alcohol drinkers (less than 20 drinks/week) Have a stable living situation with current postal address No contraindications to MR scanning (see MR scanning exclusion criteria below) 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. 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 10 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) For female volunteers, a positive pregnancy test

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kudzu extract treatment<br>Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day for a total dose of 3 grams of kudzu. | Dietary Supplement: Kudzu extract<br> <br> * Other names: Alkontrol-Herbal®;|
| Placebo Comparator: Placebo<br>Placebo will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day. | Dietary Supplement: Kudzu extract<br> <br> * Other names: Alkontrol-Herbal®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate at which alcohol enters the brain | To determine the effects of kudzu extract treatment on the rate at which alcohol enters the brain and to determine if this is due to a change in cerebral blood flow as measured by rapid proton magnetic resonance spectroscopy (1H-MRS). | 2.5 hours after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of alcohol and kudzu on resting state networks (RSN). |  | 2.5 hours after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol consumption, Kudzu extract, Cerebral blood flow