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Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons

Alcohol Dependence Clinical Trial

Official title:
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons

Clinical Trial Summary

This research is designed to assess if problem drinking by treatment seeking individuals can be treated (reduced) by kudzu extract pharmacotherapy plus medical management therapy.

Clinical Trial Description

Men and women participants, ages 21-60 yrs old and seeking treatment for their drinking, but otherwise physically and mentally healthy, will be recruited. Participants must meet criteria for heavy drinking* and either Alcohol Abuse or Alcohol Dependence according to DSM-IV criteria. Following a baseline period, participants will be randomized to take either kudzu extract or placebo for 10 weeks, and record and report their alcohol consumption. All participants will receive weekly medical management sessions with the study physician.

*Heavy Drinking according to the National Institute on Alcohol Abuse and Alcoholism (2007) is more than 4 drinks per day and more than 14 drinks per week for men; and for women, more than 3 drinks per day and more than 7 drinks per week. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01853293
Study type Interventional
Source Mclean Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date March 2014
View Details
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