Kudzu Treatment for Alcohol Abuse (KUDZU)
This study is currently recruiting participants.
Verified May 2012 by Mclean Hospital
Sponsor:
Mclean Hospital
Collaborator:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01596231
First received: May 9, 2012
Last updated: May 14, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Consumption |
Dietary Supplement: Kudzu Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study |
Resource links provided by NLM:
Further study details as provided by Mclean Hospital:
Primary Outcome Measures:
- Drinking behaviors [ Time Frame: Study end ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 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.
|
Dietary Supplement: Placebo
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
|
|
Active Comparator: Kudzu
Kudzu 2mg
|
Dietary Supplement: 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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596231
Contacts
| Contact: Lindsay Toto, BA | 617-855-2419 | ltoto@mclean.harvard.edu |
Locations
| United States, Massachusetts | |
| McLean Hospital | Recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Contact: Lindsay Toto, BA 617-855-2419 ltoto@mclean.harvard.edu | |
| Principal Investigator: Scott E. Lukas, Ph.D. | |
Sponsors and Collaborators
Mclean Hospital
Investigators
| Principal Investigator: | Scott E. Lukas, Ph.D. | Mclean Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Scott Lukas, Director, McLean Imaging Center, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT01596231 History of Changes |
| Other Study ID Numbers: | 2010-P-001099, Grant # AA10536 |
| Study First Received: | May 9, 2012 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mclean Hospital:
|
Alcohol consumption Kudzu extract |
Additional relevant MeSH terms:
|
Alcohol Drinking Drinking Behavior |
ClinicalTrials.gov processed this record on May 19, 2013