Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Kudzu Treatment for Alcohol Abuse (KUDZU)

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.
 
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:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Alcohol Consumption
Interventions Dietary Supplement: Kudzu
Dietary Supplement: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Kudzu
Hide Arm/Group Description

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.

Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Kudzu 2mg

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.

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Placebo Kudzu Total
Hide Arm/Group Description

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.

Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Kudzu 2mg

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.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
24.6  (3.3) 22.6  (3.7) 23.6  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
20
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
9
  90.0%
9
  90.0%
18
  90.0%
More than one race
1
  10.0%
1
  10.0%
2
  10.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic or Latino
1
  10.0%
0
   0.0%
1
   5.0%
Not Hispanic or Latino
9
  90.0%
10
 100.0%
19
  95.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Drinking Behaviors
Hide Description 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).
Time Frame Study end
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Kudzu
Hide Arm/Group Description:
Placebo did not alter alcohol consumption compared to baseline.
Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: beers consumed
3.4  (1.1) 1.9  (1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Kudzu
Hide Arm/Group Description

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.

Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session

Kudzu 2mg

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.

All-Cause Mortality
Placebo Kudzu
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Kudzu
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Kudzu
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott E. Lukas, Ph.D.
Organization: McLean Hospital
Phone: 617-855-2767
EMail: slukas@mclean.harvard.edu
Layout table for additonal information
Responsible Party: Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01596231    
Other Study ID Numbers: 2010-P-001099
Grant # AA10536 ( Other Grant/Funding Number: NIAAA )
First Submitted: May 9, 2012
First Posted: May 10, 2012
Results First Submitted: October 15, 2014
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014