Clinical trial NCT01853293: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alcohol Abuse
Alcohol Dependence
Heavy Drinking Days
Keywords: Alcohol Abuse
Alcohol Dependence
Heavy drinking days
Kudzu
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of heavy drinking days
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital, Behavioral Psychopharmacology Research Laboratory
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: David M. Penetar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: