Status:
WITHDRAWN
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
Lead Sponsor:
Mclean Hospital
Conditions:
Alcohol Abuse
Alcohol Dependence
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
Brief 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.
Detailed 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 dri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01853293
Start Date
March 1 2014
Last Update
October 7 2015
Active Locations (1)
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1
McLean Hospital, Behavioral Psychopharmacology Research Laboratory
Belmont, Massachusetts, United States, 02478