Addressing Heavy Alcohol Use Consumption With Kudzu (A-HACK)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Self-reported anal or vaginal sex in the prior three months while under the influence of alcohol
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 or HIV positive with a medical record documentation of HIV infection*
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 research team will postpone their enrollment for at least one month after their diagnosis.)
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
current CD4 count < 200 cells/mm3
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 moderate to severe substance-use disorder (exclusive of nicotine) as determined by DSM-V SCID criteria
any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures
not having a cell phone that can send and receive text messages.