Puerarin Effects on Alcohol Drinking - Full Text View

Puerarin Effects on Alcohol Drinking (PAD)

This study is currently recruiting participants.

Verified by Mclean Hospital, February 2009

First Received: February 27, 2009 No Changes Posted

Sponsored by:	Mclean Hospital
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00854724

Purpose

This research is designed to assess the impact of pretreatment with puerarin (NPI-031G), a major ingredient in the plant kudzu, on alcohol drinking.

Hypothesis: Short-term treatment with this compound will reduce alcohol self-administration in a simulated natural settings laboratory.

Condition	Intervention	Phase
Alcohol Abuse	Drug: Puerarin	Phase II

MedlinePlus related topics: Alcohol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

Amount of alcohol consumed [ Time Frame: During a 90 minute drinking session ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Puerarin: Active Comparator	Drug: Puerarin 400 mg, three times a day for 7 days
Placebo: Placebo Comparator	Drug: Puerarin 400 mg, three times a day for 7 days

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

moderate to heavy alcohol drinkers (20+ drinks per week)

Exclusion Criteria:

alcohol dependence or treatment-seeking drinkers
other drug abuse or dependence
psychiatric disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854724

Contacts

Contact: David Penetar

617-855-2359

dpenetar@mclean.harvard.edu

Locations

United States, Massachusetts
McLean Hospital, Behavioral Psychopharmacology Research Laboratory	Recruiting
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

Investigators

Principal Investigator:

David M. Penetar, PhD

Mclean Hospital

More Information

Additional Information:

Information about the Behavioral Psychopharmacology Research Laboratory This link exits the ClinicalTrials.gov site

Publications:

Lukas SE, Penetar D, Berko J, Vicens L, Palmer C, Mallya G, Macklin EA, Lee DY. An extract of the Chinese herbal root kudzu reduces alcohol drinking by heavy drinkers in a naturalistic setting. Alcohol Clin Exp Res. 2005 May;29(5):756-62.

Responsible Party:	McLean Hospital ( David M. Penetar )
Study ID Numbers:	P-000726, R44AA152200
Study First Received:	February 27, 2009
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00854724 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vasodilator Agents
Mental Disorders
Alcoholism
Substance-Related Disorders
Drinking Behavior
Disorders of Environmental Origin

Alcohol-Related Disorders
Cardiovascular Agents
Alcohol Drinking
Puerarin
Ethanol

Additional relevant MeSH terms:

Vasodilator Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Drinking Behavior

Disorders of Environmental Origin
Alcohol-Related Disorders
Cardiovascular Agents
Alcohol Drinking
Pharmacologic Actions
Puerarin

ClinicalTrials.gov processed this record on May 06, 2009