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NCT00854724 Clinical Trial

Puerarin Effects on Alcohol Drinking

Alcohol Abuse Clinical Trial

— PAD  

Official title:
Puerarin (NPI-031G) Effects on Alcohol Drinking - A Natural Settings Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00854724
Other study ID # P-000726
Secondary ID R44AA152200
Status Completed
Phase Phase 2
First received February 27, 2009
Last updated September 1, 2011
Start date February 2009
Est. completion date July 2011

Study information
Verified date September 2011
Source Mclean Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date July 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Puerarin, Placebo
400 mg, three times a day for 7 days

Locations
Country Name City State
United States McLean Hospital, Behavioral Psychopharmacology Research Laboratory Belmont Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of Alcohol Consumed During a 90 minute drinking session No
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