Kudzu Treatment for Alcohol Abuse (KUDZU)

This study is currently recruiting participants. (see Contacts and Locations)
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
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.

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 July 31, 2014