Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mclean Hospital
Treatments:
Ethanol
Criteria
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.