Phase 2 N=120 Randomized Triple-blind Treatment

Addressing Heavy Alcohol Use Consumption With Kudzu

Alcohol Use Disorder · Sexually Transmitted Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03709043 ↗

Enrolled (actual)

120

Serious AEs

0.8%

Results posted

May 2026

Primary outcome: Primary: Number of Binge Drinking Days — 2.15; 2.15; 1.94; 2.21 number of days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Standardized kudzu (Drug); Placebo (Other); Sexually transmitted infection testing: (Diagnostic_test); Medical Management (MM) counseling for alcohol use: (Behavioral); Urinalysis for novel alcohol biochemical markers for recent alcohol use: (Diagnostic_test); Dried Blood Spot (DBS) Testing for PEth: (Diagnostic_test); Behavioral survey measurements: (Behavioral); Ecological Momentary Assessment procedure: (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Glenn-Milo Santos
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Binge Drinking Days	2.15; 2.15; 1.94; 2.21; 2.07; 1.90	—
SECONDARY Number of Participants With Ethyl Glucuronide (EtG) Positive Urine Samples	29; 32	—

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.

Eligibility Criteria

Inclusion Criteria

Self-reported anal or vaginal sex in the prior three months while under the influence of alcohol, or reported missing ART or PrEP due to alcohol use in the prior 3 months;
at least one binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women) session per week in the prior three months;
having an AUD by DSM-5 SCID criteria (includes hazardous and harmful use);
interested in reducing binge alcohol consumption;
HIV negative by rapid antibody test and HIV pooled RNA test; or HIV positive with a medical record documentation of HIV infection.* For HIV-positive individuals, having a CD4 cell count >100 cells/mm3 and having suppressed HIV viral load with 5 times upper limit of normal);
impaired renal function (creatinine clearance < 50 ml/min);
currently participating in another intervention research study with potential overlap;
current severe substance-use disorder (exclusive of nicotine, cannabis or alcohol) as determined by DSM-V SCID criteria;
pregnant women;
HIV positive individuals who are not virally suppressed;
any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures
not willing to learn how to send EMA surveys.

(*Note: Eligible participants who have a partner currently in the study will be enrolled and randomized after their partner has completed their in-treatment follow-up, to reduce the concerns of contamination between treatment conditions. Additionally, we will exclude individuals with impaired renal function as a general precaution. Pharmacokinetic data on kudzu is limited. Puerarin is present in the urine of rats for 4-72 hours after oral administration, thus there is renal elimination of the active compound, as well as it's metabolite, equol. For this reason, we prefer to be cautious by limiting enrollment to those with reasonable renal function. We selected eGFR < 50mL/min as that is the level at which most products with renal clearance begin to demonstrate risks of increased toxicity.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03709043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.