Addressing Heavy Alcohol Use Consumption With Kudzu
A-HACK
A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedStudy Start
First participant enrolled
July 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedResults Posted
Study results publicly available
May 1, 2026
CompletedMay 1, 2026
April 1, 2026
4.7 years
October 12, 2018
October 3, 2025
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Binge Drinking Days
Binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women)
Past 7 days, weekly for 12 weeks (e.g., Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12)
Secondary Outcomes (1)
Number of Participants With Ethyl Glucuronide (EtG) Positive Urine Samples
7 days
Other Outcomes (3)
Number of Sexual Intercourse Partners
30 days
Number of Condomless Sexual Intercourse Events
30 days
Number of Participants Testing Positive of Sexually Transmitted Diseases
30 days
Study Arms (2)
Kudzu
EXPERIMENTALStandardized kudzu
Control
PLACEBO COMPARATORPlacebo
Interventions
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.
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.
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.
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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 \< 50 copies/mm3; \*
- no current acute illnesses requiring prolonged medical care;
- no chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and adhere to visit schedule;
- age 18-70 years;
- baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history;
- (\*Note: Participants newly diagnosed with HIV at screening are eligible for the study but we will postpone their enrollment until they are virally suppressed with HIV viral load \< 50 copies/mm .)
You may not qualify if:
- Any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the study;
- known allergy/previous adverse reaction to kudzu;
- moderate/severe liver disease (AST, ALT \> 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Department of Public Health
San Francisco, California, 94102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Outcome measures around binge drinking days and sexual behaviors are based on self-report, which may be subject to social desirability and recall bias. The urinary measures for alcohol metabolites for ethyl glucuronide are limited to a 2-3 day detection period, which may miss less recent alcohol consumption.
Results Point of Contact
- Title
- Glenn-Milo Santos, Professor
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Glenn-Milo Santos, PhD, MPH
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 12, 2018
First Posted
October 17, 2018
Study Start
July 11, 2019
Primary Completion
April 1, 2024
Study Completion
June 1, 2024
Last Updated
May 1, 2026
Results First Posted
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share