Back to resultsUse of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
Primary Purpose
Alcohol Abuse, Alcohol Dependence, Heavy Drinking Days
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Kudzu extract
Placebo
Medical Management
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol Abuse, Alcohol Dependence, Heavy drinking days, Kudzu
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.
Sites / Locations
- McLean Hospital, Behavioral Psychopharmacology Research Laboratory
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Kudzu extract
Placebo
Arm 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.).
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.).
Outcomes
Primary Outcome Measures
Percentage of heavy drinking days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01853293
Brief Title
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
Official Title
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Grant was not funded
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence, Heavy Drinking Days
Keywords
Alcohol Abuse, Alcohol Dependence, Heavy drinking days, Kudzu
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kudzu extract
Arm Type
Active Comparator
Arm 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.).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.).
Intervention Type
Drug
Intervention Name(s)
Kudzu extract
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Behavioral
Intervention Name(s)
Medical Management
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of heavy drinking days
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Penetar, Ph.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital, Behavioral Psychopharmacology Research Laboratory
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
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