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

This study has been withdrawn prior to enrollment.
(Funding was not received for this study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01739842
First Posted: December 4, 2012
Last Update Posted: October 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
  Purpose
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).

Condition Intervention Phase
Alcohol Consumption Cerebral Blood Flow Dietary Supplement: Kudzu extract Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Further study details as provided by Scott Lukas, Mclean Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • Impact of alcohol and kudzu on resting state networks (RSN). [ Time Frame: 2.5 hours after drug administration ]

Enrollment: 0
Study Start Date: November 2012
Study Completion Date: October 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01739842     History of Changes
Other Study ID Numbers: 2012-P-001780
AA10536 ( Other Grant/Funding Number: NIAAA )
First Submitted: November 13, 2012
First Posted: December 4, 2012
Last Update Posted: October 27, 2015
Last Verified: October 2015

Keywords provided by Scott Lukas, Mclean Hospital:
Alcohol consumption
Kudzu extract
Cerebral blood flow

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs