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

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ClinicalTrials.gov Identifier: NCT01853293
Recruitment Status : Withdrawn (Grant was not funded)
First Posted : May 14, 2013
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):
David M. Penetar, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Alcohol Dependence Heavy Drinking Days Drug: Kudzu extract Drug: Placebo Behavioral: Medical Management Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Use of Kudzu Extract in the Study of Its Ability to Reduce Alcohol Drinking in Treatment Seeking Alcohol Dependent Persons
Study Start Date : March 2014
Actual Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: 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.).
Drug: Kudzu extract
Behavioral: 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).

Placebo Comparator: 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.).
Drug: Placebo
Behavioral: 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).




Primary Outcome Measures :
  1. Percentage of heavy drinking days [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853293


Locations
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United States, Massachusetts
McLean Hospital, Behavioral Psychopharmacology Research Laboratory
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Investigators
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Principal Investigator: David M. Penetar, Ph.D. Mclean Hospital
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Responsible Party: David M. Penetar, Psychologist, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01853293    
Other Study ID Numbers: P-000727
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015
Keywords provided by David M. Penetar, Mclean Hospital:
Alcohol Abuse
Alcohol Dependence
Heavy drinking days
Kudzu
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior