Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
| Status: | Withdrawn |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
