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Trial record 40 of 1927 for:    Sexually Transmitted Diseases | NIH

Addressing Heavy Alcohol Use Consumption With Kudzu (A-HACK)

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ClinicalTrials.gov Identifier: NCT03709043
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Sexually Transmitted Diseases Drug: Standardized kudzu Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A-HACK Project: Addressing Heavy Alcohol Use Consumption With Kudzu
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Kudzu
Standardized kudzu
Drug: Standardized kudzu
Standardized kudzu

Placebo Comparator: Control
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. number of binge drinking days [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. proportion of ethyl glucuronide (EtG) positive urines [ Time Frame: 7 days ]

Other Outcome Measures:
  1. number of sexual intercourse partners [ Time Frame: 30 days ]
  2. number of condomless sexual intercourse events [ Time Frame: 30 days ]
  3. proportion of participants testing positive of sexually transmitted diseases [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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.)

Exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709043


Contacts
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Contact: Glenn-Milo Santos, PhD, MPH 415-437-6231 glenn-milo.santos@ucsf.edu
Contact: Justine Arenander, MSW justine.arenander@sfdph.org

Sponsors and Collaborators
University of California, San Francisco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Glenn-Milo Santos, PhD, MPH University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03709043     History of Changes
Other Study ID Numbers: 18-25073
R01AA025930-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Alcohol Drinking
Alcoholism
Drinking Behavior
Infection