Addressing Heavy Alcohol Use Consumption With Kudzu

Summary

Participation Requirements

Description

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 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.

Tracking Information