Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Alcohol Consumption Clinical Trial

— Kudzu MRS  

Official title:

Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01739842
• Other study ID #: 2012-P-001780
• Secondary ID: AA10536
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: November 13, 2012
• Last updated: October 26, 2015
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 40 Years

Eligibility

Inclusion Criteria:

• Capable of understanding and complying with the protocol

• Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, no psychopathologies)

• Body Mass Index between 18-30, inclusive

• Age 21-40 years

• Moderate alcohol drinkers (less than 20 drinks/week)

• Have a stable living situation with current postal address

• No contraindications to MR scanning (see MR scanning exclusion criteria below)

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.

• 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 10 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)

• For female volunteers, a positive pregnancy test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Consumption
• Alcohol Drinking
• Cerebral Blood Flow

Intervention

Dietary Supplement:
• Kudzu extract

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mclean Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate at which alcohol enters the brain	To determine the effects of kudzu extract treatment on the rate at which alcohol enters the brain and to determine if this is due to a change in cerebral blood flow as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).	2.5 hours after drug administration	No
Secondary	Impact of alcohol and kudzu on resting state networks (RSN).		2.5 hours after drug administration	No