NCT00854724

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1 month until next milestone

Results Posted

Study results publicly available

August 12, 2011

Completed
Last Updated

September 9, 2011

Status Verified

September 1, 2011

Enrollment Period

2.1 years

First QC Date

February 27, 2009

Results QC Date

July 19, 2011

Last Update Submit

September 1, 2011

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

  • Amount of Alcohol Consumed

    During a 90 minute drinking session

Study Arms (2)

Puerarin

ACTIVE COMPARATOR
Drug: Puerarin, Placebo

Placebo

PLACEBO COMPARATOR

Sugar beet filler in capsule

Drug: Puerarin, Placebo

Interventions

Puerarin, PlaceboDRUG

400 mg, three times a day for 7 days

Also known as: Puerarin: NPI-031G, Placebo: Sugar beet extract
PlaceboPuerarin

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital, Behavioral Psychopharmacology Research Laboratory

Belmont, Massachusetts, 02478, United States

Location

Related Publications (1)

  • 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. doi: 10.1097/01.alc.0000163499.64347.92.

    PMID: 15897719BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

puerarin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
David M. Penetar
Organization
BPRL, McLean Hospital
dpenetar@mclean.harvard.edu
617-855-2913

Study Officials

  • David M. Penetar, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 3, 2009

Study Start

February 1, 2009

Primary Completion

March 1, 2011

Study Completion

July 1, 2011

Last Updated

September 9, 2011

Results First Posted

August 12, 2011

Record last verified: 2011-09

Locations

US(1)