Summary

for people ages 18-70 (full criteria)
healthy people welcome
study started
estimated completion:
Glenn-Milo Santos

Description

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.

Official Title

A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu

Keywords

Alcohol Use Disorder Sexually Transmitted Diseases Alcohol Drinking Standardized kudzu Kudzu

Eligibility

You can join if…

Open to people ages 18-70

  1. Self-reported anal or vaginal sex in the prior three months while under the influence of alcohol
  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 or HIV positive with a medical record documentation of HIV infection*
  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 research team will postpone their enrollment for at least one month after their diagnosis.)

You CAN'T join if...

  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. current CD4 count < 200 cells/mm3
  4. moderate/severe liver disease (AST, ALT > 5 times upper limit of normal)
  5. impaired renal function (creatinine clearance < 50 ml/min)
  6. currently participating in another intervention research study with potential overlap
  7. current moderate to severe substance-use disorder (exclusive of nicotine) as determined by DSM-V SCID criteria
  8. any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures
  9. not having a cell phone that can send and receive text messages.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03709043
Phase
Phase 2
Lead Scientist
Glenn-Milo Santos
Study Type
Interventional
Last Updated