Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment

NCT01739842 | Withdrawn Phase 2

• 2 other identifiers: 2012-P-001780AA10536
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Alcohol Consumption; Cerebral Blood Flow

Keywords

Alcohol consumption; Kudzu extract; Cerebral blood flow

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Impact of alcohol and kudzu on resting state networks (RSN).

  2.5 hours after drug administration

Study Arms (2)

Kudzu extract treatment

ACTIVE COMPARATOR

Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day for a total dose of 3 grams of kudzu.

Dietary Supplement: Kudzu extract

Placebo

PLACEBO COMPARATOR

Placebo will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day.

Dietary Supplement: Kudzu extract

Interventions

Kudzu extract DIETARY_SUPPLEMENT

Also known as: Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®

Kudzu extract treatment; Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, McLean Imaging Center

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: October 27, 2015

Record last verified: 2015-10