Kudzu Treatment for Alcohol Abuse (KUDZU)

This study is currently recruiting participants.
Verified May 2012 by Mclean Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01596231
First received: May 9, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.


Condition Intervention Phase
Alcohol Consumption
Dietary Supplement: Kudzu
Dietary Supplement: Placebo
Phase 2

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: Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Drinking behaviors [ Time Frame: Study end ] [ Designated as safety issue: No ]
    A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Dietary Supplement: Placebo
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Active Comparator: Kudzu
Kudzu 2mg
Dietary Supplement: Kudzu
Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.
Other Names:
  • Kudzu root extract (NPI-031)
  • Puerariae lobata
  • Alkontrol-Herbal®

Detailed Description:

In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.

  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)
  • Body Mass Index between 18-30, inclusive
  • Age 21-40 years
  • Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
  • Have a stable living situation with current postal address

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.
  • Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
  • 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 5 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)
  • Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
  • For female volunteers, a positive pregnancy test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596231

Contacts
Contact: Lindsay Toto, BA 617-855-2419 ltoto@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Lindsay Toto, BA    617-855-2419    ltoto@mclean.harvard.edu   
Principal Investigator: Scott E. Lukas, Ph.D.         
Sponsors and Collaborators
Mclean Hospital
Investigators
Principal Investigator: Scott E. Lukas, Ph.D. Mclean Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Scott Lukas, Director, McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01596231     History of Changes
Other Study ID Numbers: 2010-P-001099, Grant # AA10536
Study First Received: May 9, 2012
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mclean Hospital:
Alcohol consumption
Kudzu extract

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on April 20, 2014