Addressing Heavy Alcohol Use Consumption With Kudzu

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Glenn-Milo Santos; University of California, San Francisco
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.)