Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment (Kudzu MRS)

Mass General Brigham

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Cerebral Blood Flow; Alcohol Consumption

Treatments: Dietary Supplement: Kudzu extract

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01739842

AA10536 (Other Grant/Funding Number)

2012-P-001780

Details and patient eligibility

About

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).

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Kudzu extract treatment

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Kudzu extract

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Kudzu extract