- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03709043
Addressing Heavy Alcohol Use Consumption With Kudzu (A-HACK)
A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu
Study Overview
Status
Intervention / Treatment
- Other: Placebo
- Drug: Standardized kudzu
- Diagnostic test: Sexually transmitted infection testing:
- Behavioral: Medical Management (MM) counseling for alcohol use:
- Diagnostic test: Urinalysis for novel alcohol biochemical markers for recent alcohol use:
- Diagnostic test: Dried Blood Spot (DBS) Testing for PEth:
- Behavioral: Behavioral survey measurements:
- Behavioral: Ecological Momentary Assessment procedure:
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Glenn-Milo Santos, PhD, MPH
- Phone Number: 415-437-6231
- Email: glenn-milo.santos@ucsf.edu
Study Contact Backup
- Name: Janet M Ikeda, MA
- Email: janet.ikeda@sfdph.org
Study Locations
-
-
California
-
San Francisco, California, United States, 94102
- San Francisco Department of Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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;
- 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;
- having an AUD by DSM-5 SCID criteria (includes hazardous and harmful use);
- interested in reducing binge alcohol consumption;
- 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; *
- no current acute illnesses requiring prolonged medical care;
- no chronic illnesses that are likely to progress clinically during trial participation;
- able and willing to provide informed consent and adhere to visit schedule;
- age 18-70 years;
- 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:
- Any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the study;
- known allergy/previous adverse reaction to kudzu;
- moderate/severe liver disease (AST, ALT > 5 times upper limit of normal);
- impaired renal function (creatinine clearance < 50 ml/min);
- currently participating in another intervention research study with potential overlap;
- current severe substance-use disorder (exclusive of nicotine, cannabis or alcohol) as determined by DSM-V SCID criteria;
- pregnant women;
- HIV positive individuals who are not virally suppressed;
- any condition that, in the principal investigator and/or study clinician's judgment interferes with safe study participation or adherence to study procedures
- 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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control
Placebo
|
Placebo
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
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.
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.
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.
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.
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
|
Experimental: Kudzu
Standardized kudzu
|
Standardized kudzu
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
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.
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.
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.
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.
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of binge drinking days
Time Frame: 7 days
|
Binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of ethyl glucuronide (EtG) positive urines
Time Frame: 7 days
|
Urine samples will be collected weekly and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days.
|
7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of sexual intercourse partners
Time Frame: 30 days
|
Self-reported sexual intercourse partners
|
30 days
|
number of condomless sexual intercourse events
Time Frame: 30 days
|
Self-reported of condomless sexual intercourse events
|
30 days
|
proportion of participants testing positive of sexually transmitted diseases
Time Frame: 30 days
|
all participants will be tested for syphilis (serum RPR), Neisseria gonorrhea and Chlamydia trachomatis (urine, pharyngeal swab, and rectal swab nucleic acid amplification at baseline and Month 3 visits
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Glenn-Milo Santos, PhD, MPH, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Infections
- Communicable Diseases
- Disease Attributes
- Urogenital Diseases
- Genital Diseases
- Alcohol Drinking
- Alcoholism
- Sexually Transmitted Diseases
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Central Nervous System Depressants
- Ethanol
Other Study ID Numbers
- 18-25073
- R01AA025930-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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