Study: NCT03709043

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Standardized kudzu
Description: Standardized kudzu

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Sexually transmitted infection testing:
Description: At baseline and month 3 visits, all participants will be tested for syphilis (serum RPR), Neisseria gonorrhea and Chlamydia trachomatis (urine, pharyngeal swab, and rectal swab nucleic acid amplification \[NAAT\]) through an established protocol that has been validated by our Public Health Laboratory (PHL) and others.145-149

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Sexually transmitted infection testing:
Description: At baseline and month 3 visits, all participants will be tested for syphilis (serum RPR), Neisseria gonorrhea and Chlamydia trachomatis (urine, pharyngeal swab, and rectal swab nucleic acid amplification \[NAAT\]) through an established protocol that has been validated by our Public Health Laboratory (PHL) and others.145-149

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Medical Management (MM) counseling for alcohol use:
Description: MM has been used in a targeted pharmacotherapy trial98 and our team has successfully used MM in AUD trials. MM is a low-intensity supportive program designed to increase problem recognition and enhance motivation to change maladaptive alcohol use patterns. Participants will receive individual 20 minute MM sessions weekly from trained staff supervised by a clinical psychologist.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Medical Management (MM) counseling for alcohol use:
Description: MM has been used in a targeted pharmacotherapy trial98 and our team has successfully used MM in AUD trials. MM is a low-intensity supportive program designed to increase problem recognition and enhance motivation to change maladaptive alcohol use patterns. Participants will receive individual 20 minute MM sessions weekly from trained staff supervised by a clinical psychologist.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Urinalysis for novel alcohol biochemical markers for recent alcohol use:
Description: Urine samples will be collected at Enrollment, Month 1, Month 2 and Month 3 visits and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days. EtG is a relatively novel, highly sensitive indicator for recent alcohol consumption; this alcohol biomarker is detectable in urine for approximately 72 hours.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Urinalysis for novel alcohol biochemical markers for recent alcohol use:
Description: Urine samples will be collected at Enrollment, Month 1, Month 2 and Month 3 visits and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days. EtG is a relatively novel, highly sensitive indicator for recent alcohol consumption; this alcohol biomarker is detectable in urine for approximately 72 hours.

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Dried Blood Spot (DBS) Testing for PEth:
Description: DBS samples will be collected at enrollment, weeks 12, and post-treatment visits at month 3. Samples will be dried overnight using standardized methods. PEth testing of DBS samples will be conducted at the United States Drug Testing Laboratories in Des Plaines, IL using liquid chromatography-tandem mass spectrometry system following extraction into methanol.

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Dried Blood Spot (DBS) Testing for PEth:
Description: DBS samples will be collected at enrollment, weeks 12, and post-treatment visits at month 3. Samples will be dried overnight using standardized methods. PEth testing of DBS samples will be conducted at the United States Drug Testing Laboratories in Des Plaines, IL using liquid chromatography-tandem mass spectrometry system following extraction into methanol.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Behavioral survey measurements:
Description: Standardized and validated behavioral measures will be assessed using audio computer administered surveys (ACASI) to minimize underreporting of risk activities and standardize data collection.152,153 To minimize potential social desirability bias, staff will not have access to data during the trial. The draft of the ACASI survey instrument is included in the appendix.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Behavioral survey measurements:
Description: Standardized and validated behavioral measures will be assessed using audio computer administered surveys (ACASI) to minimize underreporting of risk activities and standardize data collection.152,153 To minimize potential social desirability bias, staff will not have access to data during the trial. The draft of the ACASI survey instrument is included in the appendix.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Ecological Momentary Assessment procedure:
Description: Participants will receive daily SMS texts to collect data on alcohol consumption, number of drinks on drinking days, targeted medication administration prior to anticipated drinking sessions, and sexual risk behaviors

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Ecological Momentary Assessment procedure:
Description: Participants will receive daily SMS texts to collect data on alcohol consumption, number of drinks on drinking days, targeted medication administration prior to anticipated drinking sessions, and sexual risk behaviors