Addressing Heavy Alcohol Use Consumption With Kudzu (A-HACK)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    120
  • sponsor
    Glenn-Milo Santos
Updated on 4 October 2022
HIV Infection
heavy drinking
drug abuse
scid
antibody response
Accepts healthy volunteers

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.

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 (see Figure 2) 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.

Details
Condition Alcohol Use Disorder, Sexually Transmitted Diseases
Treatment Placebo, Standardized kudzu, Sexually transmitted infection testing:, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers for recent alcohol use:, Dried Blood Spot (DBS) Testing for PEth:, Behavioral survey measurements:, Ecological Momentary Assessment procedure:
Clinical Study IdentifierNCT03709043
SponsorGlenn-Milo Santos
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 < 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 <
copies/mm .)

Exclusion Criteria

Any psychiatric (e.g., depression with suicidal ideation) or medical condition that
known allergy/previous adverse reaction to kudzu
would preclude safe participation in the study
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
pregnant women
current severe substance-use disorder (exclusive of nicotine, cannabis or alcohol) as
HIV positive individuals who are not virally suppressed
determined by DSM-V SCID criteria
not willing to learn how to send EMA surveys
any condition that, in the principal investigator and/or study clinician's judgment
interferes with safe study participation or adherence to study procedures
(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.)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note