Phase 2
Completed N=20
Kudzu Treatment for Alcohol Abuse
Alcohol Consumption
Source: ClinicalTrials.gov NCT01596231 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Drinking Behaviors — 3.4; 1.9 beers consumed
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drinking Behaviors |
3.4; 1.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01596231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.