Kudzu Treatment for Alcohol Abuse (KUDZU)

• ClinicalTrials.gov Identifier: NCT01596231
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Results First Posted: October 21, 2014
• Last Update Posted: October 21, 2014
• Sponsor: Mclean Hospital
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Scott Lukas, Mclean Hospital

Tracking Information

• First Submitted Date: May 9, 2012
• First Posted Date: May 10, 2012
• Results First Submitted Date: October 15, 2014
• Results First Posted Date: October 21, 2014
• Last Update Posted Date: October 21, 2014
• Study Start Date: May 2010
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2014)

Drinking Behaviors [ Time Frame: Study end ]

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).

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Kudzu Treatment for Alcohol Abuse
• Official Title: Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Alcohol Consumption

Intervention

• 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®
• Dietary Supplement: Placebo
  Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Study Arms

• 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.
  Intervention: Dietary Supplement: Placebo
• Active Comparator: Kudzu
  Kudzu 2mg
  Intervention: Dietary Supplement: Kudzu

• Publications *: Penetar DM, Toto LH, Lee DY, Lukas SE. A single dose of kudzu extract reduces alcohol consumption in a binge drinking paradigm. Drug Alcohol Depend. 2015 Aug 1;153:194-200. doi: 10.1016/j.drugalcdep.2015.05.025. Epub 2015 May 27.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 15, 2014): 20
• Original Estimated Enrollment (submitted: May 9, 2012): 30
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01596231
• Other Study ID Numbers: 2010-P-001099; Grant # AA10536 ( Other Grant/Funding Number: NIAAA )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Scott Lukas, Mclean Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Mclean Hospital
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Scott E. Lukas, Ph.D.; Mclean Hospital

• PRS Account: Mclean Hospital
• Verification Date: October 2014