Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-10-31

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).

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Detailed Description

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Conditions

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Alcohol Consumption Cerebral Blood Flow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kudzu extract treatment

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.

Group Type ACTIVE_COMPARATOR

Kudzu extract

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Group Type PLACEBO_COMPARATOR

Kudzu extract

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Kudzu extract

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Kudzu root extract (NPI-031) Puerariae lobata Alkontrol-Herbal®

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

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes