Summary

Eligibility
for people ages 18-70 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Glenn-Milo Santos (ucsf)
Headshot of Glenn-Milo Santos
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

Details

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.

Keywords

Alcohol Use Disorder, Sexually Transmitted Diseases, Alcoholism, Alcohol Drinking, Ethanol, Standardized kudzu, Sexually transmitted infection testing:, Urinalysis for novel alcohol biochemical markers for recent alcohol use:, Dried Blood Spot (DBS) Testing for PEth:, Ecological Momentary Assessment procedure:, Kudzu

Eligibility

Location

  • San Francisco Department of Public Health
    San Francisco California 94102 United States

Lead Scientist at University of California Health

  • Glenn-Milo Santos (ucsf)
    I am Professor in the Department of Community Health Systems and the Division of Prevention Science at the University of California, San Francisco, and a Senior Research Scientist at the San Francisco Department of Public Health.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Glenn-Milo Santos
ID
NCT03709043
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 120 people participating
Last Updated