Alcohol Consumption
Conditions
Keywords
Alcohol consumption, Kudzu extract
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.
Interventions
DIETARY_SUPPLEMENTKudzu
Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.
DIETARY_SUPPLEMENTPlacebo
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinking Behaviors | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session | 10 |
| Kudzu Kudzu 2mg
Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Total | Placebo | Kudzu |
|---|---|---|---|
| Age, Continuous | 23.6 years STANDARD_DEVIATION 6.2 | 24.6 years STANDARD_DEVIATION 3.3 | 22.6 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 9 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 9 Participants | 9 Participants |
| Region of Enrollment United States | 20 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Drinking Behaviors
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).
Time frame: Study end
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Drinking Behaviors | 3.4 beers consumed | Standard Deviation 1.1 |
| Kudzu | Drinking Behaviors | 1.9 beers consumed | Standard Deviation 1.3 |