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Puerarin Effects on Alcohol Drinking (PAD)

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ClinicalTrials.gov Identifier: NCT00854724
Recruitment Status : Completed
First Posted : March 3, 2009
Results First Posted : August 12, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by (Responsible Party):
David M. Penetar, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Drug: Puerarin, Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study
Study Start Date : February 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00854724


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

Publications:
Responsible Party: David M. Penetar, Psychologist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00854724     History of Changes
Other Study ID Numbers: P-000726
R44AA152200 ( Other Grant/Funding Number: NIAAA )
First Posted: March 3, 2009    Key Record Dates
Results First Posted: August 12, 2011
Last Update Posted: September 9, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Puerarin
Vasodilator Agents