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

• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo	Kudzu
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

Baseline Characteristics

Arm/Group Title		Placebo	Kudzu	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Drinking Behaviors
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Kudzu
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo	Kudzu
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	--/--	--/--
Serious Adverse Events
	Placebo	Kudzu
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/10 (0.00%)	0/10 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Scott E. Lukas, Ph.D.
• Organization: McLean Hospital
• Phone: 617-855-2767
• EMail: slukas@mclean.harvard.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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