Alcohol Use DisorderPhase 2A-HACKNCT03709043
Addressing Heavy Alcohol Use Consumption With Kudzu
A Phase 2 study testing Standardized kudzu, Sexually transmitted infection testing: and Medical Management (MM) counseling for alcohol use: in people with Alcohol Use Disorder and Sexually Transmitted Diseases, run by Glenn-Milo Santos at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Sexually Transmitted Diseases
- What is being tested?
- Standardized kudzu, Sexually transmitted infection testing: and Medical Management (MM) counseling for alcohol use:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 1 Jun 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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 .)
Who cannot join
- 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;
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- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu
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.
Read the detailed description
This study, entitled "The Harness Study" is a double-blind, placebo-controlled, two-arm trial in which 120 binge drinkers with AUD will be randomly assigned to receive 12 weeks of kudzu or placebo, to be taken on an as-needed basis with 1- and 3-month post-treatment follow-up visits. This efficacy study will enroll sexually active, binge drinkers with AUD because they are the most likely population to benefit from this intervention by limiting harms associated with heavy alcohol use and decreasing alcohol-related sexual risk behaviors. A study clinician will perform the Structured Clinical Interview for the DSM-V (SCID) to screen for AUD and determine eligibility. Upon enrollment, 120 participants will be randomized 1:1 to kudzu extract (2 grams) or placebo for targeted administration. Participants will be seen weekly for behavioral surveys, urinalyses, study drug dispensing, and alcohol use counseling. Safety laboratory assessment, vital signs, and the audio computer assisted survey instrument (ACASI) will be completed monthly. Efficacy, tolerability, and acceptability (Specific Aims 1-4) will be assessed upon trial completion as measured by number of binge drinking occasions and numbers of drinks on drinking days via timeline follow-back at weekly visits; number of EtG-positive urine samples; sexual risk behavior data through monthly surveys via ACASI; frequency of adverse events; and cumulative medication adherence data at week 12. Durability of intervention effects will be evaluated at 1- and 3-month post-treatment visits.
- Being tested
- Standardized kudzu, Placebo, Sexually transmitted infection testing:, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers for recent alcohol use:
- Medical subject headings
- Alcoholism, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized kudzuDrug
Standardized kudzu
PlaceboOther
Placebo
Sexually transmitted infection testing:Diagnostic test
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:Behavioural
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:Diagnostic test
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:Diagnostic test
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:Behavioural
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:Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Kudzu | Experimental | Standardized kudzu Receives: Drug: Standardized kudzu; Diagnostic Test: Sexually transmitted infection testing:; Behavioral: Medical Management (MM) counseling for alcohol use:; Diagnostic Test: Urinalysis for novel alcohol biochemical markers for recent alcohol use:; Diagnostic Test: Dried Blood Spot (DBS) Testing for PEth:; Behavioral: Behavioral survey measurements:; Behavioral: Ecological Momentary Assessment procedure: |
| Control | Placebo comparator | Placebo Receives: Other: Placebo; Diagnostic Test: Sexually transmitted infection testing:; Behavioral: Medical Management (MM) counseling for alcohol use:; Diagnostic Test: Urinalysis for novel alcohol biochemical markers for recent alcohol use:; Diagnostic Test: Dried Blood Spot (DBS) Testing for PEth:; Behavioral: Behavioral survey measurements:; Behavioral: Ecological Momentary Assessment procedure: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Binge Drinking Days
Binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women)
Measured: 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
Urine samples will be collected weekly and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start11 Jul 2019
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenn-Milo Santos
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Glenn-Milo Santos, University of California, San Francisco
- Investigators
- Glenn-Milo Santos, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709043
- Sponsor's protocol ID
- 18-25073
- Other IDs
- R01AA025930-01A1
- Acronym
- A-HACK
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2018
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gyamerah AO, Dunham AE, Ikeda J, Canizares AC, McFarland W, Wilson EC, Santos GM. Impact of the COVID-19 pandemic on violence exposure and alcohol use among adults who drink alcohol. PLoS One. 2024 Dec 31;19(12):e0316096. doi: 10.1371/journal.pone.0316096. eCollection 2024.
PubMed 39739971