Puerarin Effects on Alcohol Drinking (PAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David M. Penetar, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00854724
First received: February 27, 2009
Last updated: September 1, 2011
Last verified: September 2011
  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, Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: David M. Penetar, Psychologist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00854724     History of Changes
Other Study ID Numbers: P-000726, R44AA152200
Study First Received: February 27, 2009
Results First Received: July 19, 2011
Last Updated: September 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Puerarin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014