Use of Kudzu Extract in the Study of Its Ability to Reduc... | NCT01853293

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Grant was not funded

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Not provided

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

May 10, 2013

First Posted Date

May 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2015

Last Update Posted Date

Oct 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kudzu extract	Active Comparator	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
Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kudzu extract	Drug		Kudzu extract
Placebo

Measure	Description	Time Frame
Percentage of heavy drinking days		10 weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M. Penetar, Ph.D.	Mclean Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McLean Hospital, Behavioral Psychopharmacology Research Laboratory		Belmont	Massachusetts	02478	United States

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D020399	Practice Management
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration