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

October 26, 2015 updated by: Scott Lukas, Mclean Hospital
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: Kudzu extract
Other Names:
  • Kudzu root extract (NPI-031)
  • Puerariae lobata
  • Alkontrol-Herbal®
Placebo Comparator: 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.
Dietary supplement: Kudzu extract
Other Names:
  • Kudzu root extract (NPI-031)
  • Puerariae lobata
  • Alkontrol-Herbal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate at which alcohol enters the brain
Time Frame: 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).
2.5 hours after drug administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 28, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-P-001780
  • AA10536 (Other Grant/Funding Number: NIAAA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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