NCT01853293

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

May 10, 2013

Last Update Submit

October 6, 2015

Conditions

Alcohol AbuseAlcohol DependenceHeavy Drinking Days

Keywords

Alcohol AbuseAlcohol DependenceHeavy drinking daysKudzu

Outcome Measures

Primary Outcomes (1)

  • Percentage of heavy drinking days

    10 weeks

Study Arms (2)

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 extractBehavioral: 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: PlaceboBehavioral: Medical Management

Interventions

Kudzu extractDRUG
Kudzu extract
PlaceboDRUG
Placebo
Medical ManagementBEHAVIORAL

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).

Kudzu extractPlacebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital, Behavioral Psychopharmacology Research Laboratory

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Practice ManagementProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • David M. Penetar, Ph.D.

    Mclean Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

US(1)