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

 -  Treatment seeking for alcohol abuse or dependence.

 -  Non cigarette smokers are preferred, but will accept those who smoke less than 10
 cigarettes per day.

 -  Marijuana use of less than once per week. Other drug use less than 20 lifetime uses.

 -  Absence of current Axis I disorders except alcohol abuse or dependence. Past diagnosis
 (greater than 1 year) is acceptable.

 -  BMI within 18-30.

 -  Physically healthy (normal physical exam, ECG, blood and urine chemistries).

 -  Female participants must use medically approved method of contraception. If barrier
 method is used, must agree to using two methods simultaneously (e.g., diaphragm and
 condom).

 Exclusion Criteria:

 -  Taking any prescription medication (except oral contraceptives, certain short term
 anti -fungal agents and some topical creams for dermal conditions).

 -  On psychotropic medications.

 -  Drug use (other than nicotine, alcohol or marijuana) greater than 20 lifetime uses.

 -  Meets criteria for current drug abuse or dependence (other than alcohol and nicotine).
 Past abuse/dependence (greater than 3 years) is acceptable.

 -  History of major head trauma.

 -  History of cardiac problems.

 -  Pregnancy, lactating, or planning to become pregnant during the study period.