Addressing Heavy Alcohol Use Consumption With Kudzu

NCT ID: NCT03709043

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-11
• Study Completion Date: 2024-06-01

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.

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.

Conditions

Alcohol Use Disorder; Sexually Transmitted Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Kudzu

Standardized kudzu

Group Type: EXPERIMENTAL

Standardized kudzu

Intervention Type: DRUG

Standardized kudzu

Sexually transmitted infection testing:

Intervention Type: 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:

Intervention Type: BEHAVIORAL

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:

Intervention Type: 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:

Intervention Type: 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:

Intervention Type: BEHAVIORAL

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:

Intervention Type: BEHAVIORAL

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

Control

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Sexually transmitted infection testing:

Intervention Type: 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:

Intervention Type: BEHAVIORAL

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:

Intervention Type: 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:

Intervention Type: 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:

Intervention Type: BEHAVIORAL

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:

Intervention Type: BEHAVIORAL

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

Interventions

Standardized kudzu

Standardized kudzu

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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;

2. 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;

3. having an AUD by DSM-5 SCID criteria (includes hazardous and harmful use);

4. interested in reducing binge alcohol consumption;

5. 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; *

6. no current acute illnesses requiring prolonged medical care;

7. no chronic illnesses that are likely to progress clinically during trial participation;

8. able and willing to provide informed consent and adhere to visit schedule;

9. age 18-70 years;

10. 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 .)

Exclusion Criteria

1. Any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the study;

2. known allergy/previous adverse reaction to kudzu;

3. moderate/severe liver disease (AST, ALT > 5 times upper limit of normal);

4. impaired renal function (creatinine clearance < 50 ml/min);

5. currently participating in another intervention research study with potential overlap;

6. current severe substance-use disorder (exclusive of nicotine, cannabis or alcohol) as determined by DSM-V SCID criteria;

7. pregnant women;

8. HIV positive individuals who are not virally suppressed;

9. any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures

10. 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Glenn-Milo Santos

OTHER

Sponsor Role: lead

Responsible Party

Glenn-Milo Santos

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Glenn-Milo Santos, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco Department of Public Health

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01AA025930-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-25073

Identifier Type: -

Identifier Source: org_study_id