Addressing Heavy Alcohol Use Consumption With Kudzu (NCT03709043) | Clinical Trial Compass
CompletedPhase 2
Addressing Heavy Alcohol Use Consumption With Kudzu
United States120 participantsStarted 2019-07-11
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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;
Exclusion criteria
✕. 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);
What they're measuring
1
Number of Binge Drinking Days
Timeframe: Past 7 days, weekly for 12 weeks (e.g., Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12)