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Addressing Heavy Alcohol Use Consumption With Kudzu
Sponsor: Glenn-Milo Santos
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.
Official title: A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2019-07-11
Completion Date
2024-06-01
Last Updated
2026-05-01
Healthy Volunteers
Yes
Interventions
Standardized kudzu
Standardized kudzu
Placebo
Placebo
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.
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.
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.
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 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.
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
Locations (1)
San Francisco Department of Public Health
San Francisco, California, United States