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

NCT ID: NCT01853293

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31

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 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.

Conditions

Alcohol Abuse; Alcohol Dependence; Heavy Drinking Days

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Kudzu extract

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.).

Group Type: ACTIVE_COMPARATOR

Kudzu extract

Intervention Type: DRUG

Medical Management

Intervention Type: BEHAVIORAL

Medical Management is a manualized treatment deriving from a number of empirically tested manualized therapies designed to approximate a primary care approach to alcohol dependence. The treatment, delivered by a medical professional (i.e., nurse or physician), monitors medication side effects, provides strategies to increase medication adherence and supports abstinence through psychoeducation and referral to groups such as Alcoholics Anonymous. The visits allow for assessments of drinking, overall functioning, medication adherence, and side effects. Also at one of these weekly visits, a blood sample will be taken for liver function tests (GGT, ALT, AST). Samples will be further analyzed for two measures of heavy drinking: carbohydrate deficient transferrin (CDT) and phosphatidylethanol (PEth).

Placebo

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.).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Medical Management

Intervention Type: BEHAVIORAL

Medical Management is a manualized treatment deriving from a number of empirically tested manualized therapies designed to approximate a primary care approach to alcohol dependence. The treatment, delivered by a medical professional (i.e., nurse or physician), monitors medication side effects, provides strategies to increase medication adherence and supports abstinence through psychoeducation and referral to groups such as Alcoholics Anonymous. The visits allow for assessments of drinking, overall functioning, medication adherence, and side effects. Also at one of these weekly visits, a blood sample will be taken for liver function tests (GGT, ALT, AST). Samples will be further analyzed for two measures of heavy drinking: carbohydrate deficient transferrin (CDT) and phosphatidylethanol (PEth).

Interventions

Kudzu extract

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Medical Management

Medical Management is a manualized treatment deriving from a number of empirically tested manualized therapies designed to approximate a primary care approach to alcohol dependence. The treatment, delivered by a medical professional (i.e., nurse or physician), monitors medication side effects, provides strategies to increase medication adherence and supports abstinence through psychoeducation and referral to groups such as Alcoholics Anonymous. The visits allow for assessments of drinking, overall functioning, medication adherence, and side effects. Also at one of these weekly visits, a blood sample will be taken for liver function tests (GGT, ALT, AST). Samples will be further analyzed for two measures of heavy drinking: carbohydrate deficient transferrin (CDT) and phosphatidylethanol (PEth).

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

David M. Penetar

Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M. Penetar, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital, Behavioral Psychopharmacology Research Laboratory

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

P-000727

Identifier Type: -

Identifier Source: org_study_id