Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Mclean Hospital
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Drinking Behaviors
Study Overview
Brief Summary
This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.
Detailed Description
In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Capable of understanding and complying with the protocol
- •Good physical and mental health (normal physical exam, ECG, blood and urine chemistries)
- •Body Mass Index between 18-30, inclusive
- •Age 21-40 years
- •Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
- •Have a stable living situation with current postal address
Exclusion Criteria
- •Concurrent diagnosis of Axis I disorder
- •Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
- •Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
- •Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
- •Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
- •Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
- •Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
- •Tobacco use greater than 5 cigarettes per day
- •History of major head trauma resulting in cognitive impairment or history of seizure disorder
- •Heavy caffeine use (greater than 500 mg on a regular, daily basis)
- •Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
- •For female volunteers, a positive pregnancy test
Outcomes
Primary Outcomes
Drinking Behaviors
Time Frame: Study end
A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).
Secondary Outcomes
No secondary outcomes reported
Investigators
Scott Lukas
Director, McLean Imaging Center
Mclean Hospital