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Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment (Kudzu MRS)

Primary Purpose

Alcohol Consumption, Cerebral Blood Flow

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Kudzu extract
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption focused on measuring Alcohol consumption, Kudzu extract, Cerebral blood flow

Eligibility Criteria

21 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Kudzu extract treatment

    Placebo

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Impact of alcohol and kudzu on resting state networks (RSN).

    Full Information

    First Posted
    November 13, 2012
    Last Updated
    October 26, 2015
    Sponsor
    Mclean Hospital
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01739842
    Brief Title
    Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
    Acronym
    Kudzu MRS
    Official Title
    Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding was not received for this study.
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mclean Hospital
    Collaborators
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Consumption, Cerebral Blood Flow
    Keywords
    Alcohol consumption, Kudzu extract, Cerebral blood flow

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kudzu extract treatment
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Kudzu extract
    Other Intervention Name(s)
    Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®
    Primary Outcome Measure Information:
    Title
    Rate at which alcohol enters the brain
    Description
    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).
    Time Frame
    2.5 hours after drug administration
    Secondary Outcome Measure Information:
    Title
    Impact of alcohol and kudzu on resting state networks (RSN).
    Time Frame
    2.5 hours after drug administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

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