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Herbal Supplement

Kudzu for Alcoholism (A-HACK Trial)

Phase 2
Waitlist Available
Led By Glenn-Milo Santos, PhD, MPH
Research Sponsored by Glenn-Milo Santos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

A-HACK Trial Summary

This 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.

Who is the study for?
This trial is for adults aged 18-70 who binge drink and are at high risk for HIV, either wanting to cut down on heavy alcohol use or having unprotected sex while under the influence. Participants must be generally healthy without chronic or acute illnesses that could worsen during the study. People with severe liver disease, kidney issues, certain psychiatric conditions, or those already in overlapping studies cannot join.Check my eligibility
What is being tested?
The trial is testing if kudzu, an herbal supplement, can help reduce binge drinking and risky sexual behaviors linked to alcohol consumption among individuals at high risk for HIV. It's a double-blind study where participants won't know if they're getting kudzu or a placebo while also receiving counseling and undergoing various health tests.See study design
What are the potential side effects?
While specific side effects of kudzu aren't listed here, common reactions may include digestive upset like nausea or diarrhea. Allergic reactions are possible but should be rare since people with known allergies to kudzu aren't included in this trial.

A-HACK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had sex under the influence of alcohol or missed HIV treatments due to alcohol in the last 3 months.
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I am either HIV negative or HIV positive with a controlled infection.
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I am between 18 and 70 years old.
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I do not have any ongoing serious illnesses needing long-term treatment.

A-HACK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of binge drinking days
Secondary outcome measures
proportion of ethyl glucuronide (EtG) positive urines
Other outcome measures
number of condomless sexual intercourse events
number of sexual intercourse partners
proportion of participants testing positive of sexually transmitted diseases

A-HACK Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KudzuExperimental Treatment7 Interventions
Standardized kudzu
Group II: ControlPlacebo Group7 Interventions
Placebo

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,391 Total Patients Enrolled
422 Trials studying Alcoholism
985,088 Patients Enrolled for Alcoholism
Glenn-Milo SantosLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
Glenn-Milo Santos, PhD, MPHPrincipal Investigator - University of California, San Francisco
University of California, San Francisco
2 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Kudzu (Herbal Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03709043 — Phase 2
Alcoholism Research Study Groups: Control, Kudzu
Alcoholism Clinical Trial 2023: Kudzu Highlights & Side Effects. Trial Name: NCT03709043 — Phase 2
Kudzu (Herbal Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03709043 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the trial open to individuals under 45 years of age?

"This clinical trial is open to all individuals aged 18 to 70. There are, however, special trials for those under the legal age and over 65 with 51 and 275 studies respectively."

Answered by AI

How extensive is the current pool of participants in this experiment?

"Correct. According to the information provided by clinicaltrials.gov, this medical trial is actively seeking participants and has been edited as recently as July 22nd 2022. The research aims to recruit a total of 120 patients from one site only."

Answered by AI

Are enrollment opportunities currently available for this trial?

"According to information hosted on clinicaltrials.gov, this trial is actively accepting participants who meet the criteria posted when it was first listed in July 11th 2019 and last modified two years later."

Answered by AI

Am I eligible to partake in this medical experiment?

"To be considered for this clinical research, potential subjects must have a sexually transmissible infection and inhabit the 18-70 year old age range. The total required participants is 120 individuals."

Answered by AI

Has the FDA sanctioned Standardized kudzu for consumer use?

"Our research team at Power has awarded standardized kudzu a safety rating of 2, since this is a phase two trial. Although there have been some results confirming its safety, efficacy remains unconfirmed."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
San Francisco Department of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Addressing Heavy Alcohol Use Consumption With Kudzu
Glenn-Milo Santos 2019. "Addressing Heavy Alcohol Use Consumption With Kudzu". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03709043.
All > Alcoholism
~4 spots leftby Jun 2024
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