Addressing Heavy Alcohol Use Consumption With Kudzu

Summary

Drinking multiple alcoholic drinks on a single occasion (binge drinking), has many negative health risks but interventions to address this behavior remain limited. This double-blind, placebo-controlled randomized clinical trial will test whether kudzu, an herbal supplement, can reduce heavy alcohol use and alcohol-associated sexual behaviors among sexually-active, binge-drinking individuals at high risk for HIV infection.

Conditions

• Alcohol Use Disorder
• Sexually Transmitted Diseases

Interventions

DRUG

Standardized kudzu

Standardized kudzu

OTHER

Placebo

Placebo

DIAGNOSTIC_TEST

Sexually transmitted infection testing:

At baseline and month 3 visits, all participants will be tested for syphilis (serum RPR), Neisseria gonorrhea and Chlamydia trachomatis (urine, pharyngeal swab, and rectal swab nucleic acid amplification \[NAAT\]) through an established protocol that has been validated by our Public Health Laboratory (PHL) and others.

BEHAVIORAL

Medical Management (MM) counseling for alcohol use:

MM has been used in a targeted pharmacotherapy trial and our team has successfully used MM in AUD trials. MM is a low-intensity supportive program designed to increase problem recognition and enhance motivation to change maladaptive alcohol use patterns. Participants will receive individual 20 minute MM sessions weekly from trained staff supervised by a clinical psychologist.

DIAGNOSTIC_TEST

Urinalysis for novel alcohol biochemical markers for recent alcohol use:

Urine samples will be collected at Enrollment, Month 1, Month 2 and Month 3 visits and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days. EtG is a relatively novel, highly sensitive indicator for recent alcohol consumption; this alcohol biomarker is detectable in urine for approximately 72 hours.

DIAGNOSTIC_TEST

Dried Blood Spot (DBS) Testing for PEth:

DBS samples will be collected at enrollment, weeks 12, and post-treatment visits at month 3. Samples will be dried overnight using standardized methods. PEth testing of DBS samples will be conducted at the United States Drug Testing Laboratories in Des Plaines, IL using liquid chromatography-tandem mass spectrometry system following extraction into methanol.

BEHAVIORAL

Behavioral survey measurements:

Standardized and validated behavioral measures will be assessed using audio computer administered surveys (ACASI) to minimize underreporting of risk activities and standardize data collection.To minimize potential social desirability bias, staff will not have access to data during the trial.

BEHAVIORAL

Ecological Momentary Assessment procedure:

Participants will receive daily SMS texts to collect data on alcohol consumption, number of drinks on drinking days, targeted medication administration prior to anticipated drinking sessions, and sexual risk behaviors

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Glenn-Milo Santos

  lead OTHER

Principal Investigators

• Glenn-Milo Santos, PhD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-11

Primary Completion

2024-04-01

Completion

2024-06-01

FDA Drug

Yes

Countries

• United States

Study Locations