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

Mass General Brigham

Status and phase: Withdrawn; Phase 2

Conditions: Alcohol Abuse; Heavy Drinking Days; Alcohol Dependence

Treatments: Behavioral: Medical Management; Drug: Kudzu extract; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01853293

P-000727

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Kudzu extract

Active Comparator group

Description:

Participants will take two 500-mg capsules of Kudzu extract, t.i.d. (morning, 6:00 to 8:30 a.m.; afternoon, 2:00 to 4:30 p.m.; evening, 9:00 to 11:30 p.m.).

Treatment:

Behavioral: Medical Management

Drug: Kudzu extract

Placebo

Placebo Comparator group

Description:

Placebo capsule contains sugar beet filler. Participants will take two 500-mg capsules, t.i.d. (morning, 6:00 to 8:30 a.m.; afternoon, 2:00 to 4:30 p.m.; evening, 9:00 to 11:30 p.m.).

Treatment:

Behavioral: Medical Management

Drug: Placebo