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Puerarin Effects on Alcohol Drinking (PAD)

This study has been completed.
Information provided by (Responsible Party):
David M. Penetar, Mclean Hospital Identifier:
First received: February 27, 2009
Last updated: September 1, 2011
Last verified: September 2011
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, Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study

Resource links provided by NLM:

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Amount of Alcohol Consumed [ Time Frame: During a 90 minute drinking session ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Puerarin Drug: Puerarin, Placebo
400 mg, three times a day for 7 days
Other Names:
  • Puerarin: NPI-031G
  • Placebo: Sugar beet extract
Placebo Comparator: Placebo
Sugar beet filler in capsule
Drug: Puerarin, Placebo
400 mg, three times a day for 7 days
Other Names:
  • Puerarin: NPI-031G
  • Placebo: Sugar beet extract

Detailed Description:
Participants will have an opportunity to drink up to 6 beers, plus water and juice, during a 90 minute afternoon drinking session in our simulated apartment room laboratory. Drinking sessions will be conducted in the afternoon after participants take puerarin or placebo for 7 days.

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00854724

United States, Massachusetts
McLean Hospital, Behavioral Psychopharmacology Research Laboratory
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Principal Investigator: David M. Penetar, PhD Mclean Hospital
  More Information

Responsible Party: David M. Penetar, Psychologist, Mclean Hospital Identifier: NCT00854724     History of Changes
Other Study ID Numbers: P-000726
R44AA152200 ( Other Grant/Funding Number: NIAAA )
Study First Received: February 27, 2009
Results First Received: July 19, 2011
Last Updated: September 1, 2011

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Vasodilator Agents processed this record on May 24, 2017