Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Phase 2

Withdrawn

• Conditions: Alcohol Consumption; Cerebral Blood Flow
• Interventions: Dietary Supplement: Kudzu extract

• Registration Number: NCT01739842
• Lead Sponsor: Mclean Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-12-04
• Primary Completion: 2014-11
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-26
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kudzu extract treatment	Kudzu extract	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.
Placebo	Kudzu extract	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.

Primary Outcome Measures

Name	Time	Method
Rate at which alcohol enters the brain	2.5 hours after drug administration	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).

Secondary Outcome Measures

Name	Time	Method
Impact of alcohol and kudzu on resting state networks (RSN).	2.5 hours after drug administration