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This study has been withdrawn prior to enrollment.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:
Collaborator:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01739842
First received: November 13, 2012
Last updated: August 19, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Rate at which alcohol enters the brain [ Time Frame: 2.5 hours after drug administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (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.


  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 13, 2012
Last Updated: August 19, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on July 31, 2014