Trial Outcomes & Findings for Addressing Heavy Alcohol Use Consumption With Kudzu (NCT NCT03709043)
NCT ID: NCT03709043
Last Updated: 2026-05-01
Results Overview
Binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Past 7 days, weekly for 12 weeks (e.g., Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12)
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Kudzu
Standardized kudzu, 2 grams
|
Control
Placebo, 2 grams
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
52
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing Heavy Alcohol Use Consumption With Kudzu
Baseline characteristics by cohort
| Measure |
Kudzu
n=60 Participants
Standardized kudzu, 2 grams
|
Control
n=60 Participants
Placebo, 2 grams
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
60 Participants
n=14 Participants
|
60 Participants
n=34 Participants
|
120 Participants
n=69 Participants
|
|
Age, Continuous
|
41 years
n=14 Participants
|
36 years
n=34 Participants
|
39 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=14 Participants
|
25 Participants
n=34 Participants
|
49 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=14 Participants
|
35 Participants
n=34 Participants
|
71 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · White
|
37 Participants
n=14 Participants
|
37 Participants
n=34 Participants
|
74 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Asian and Pacific Islander
|
4 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
8 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Black
|
7 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
14 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Latinx/Latine
|
4 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
7 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnicity · Other
|
8 Participants
n=14 Participants
|
9 Participants
n=34 Participants
|
17 Participants
n=69 Participants
|
|
Alcohol Craving Score
|
18 craving score intensity
n=14 Participants
|
18 craving score intensity
n=34 Participants
|
18 craving score intensity
n=69 Participants
|
|
Number of binge drinking days, past week
|
2.15 days
STANDARD_DEVIATION 1.91 • n=14 Participants
|
2.15 days
STANDARD_DEVIATION 1.90 • n=34 Participants
|
2.15 days
STANDARD_DEVIATION 1.91 • n=69 Participants
|
|
Urine positive for alcohol use
|
17 Participants
n=14 Participants
|
23 Participants
n=34 Participants
|
40 Participants
n=69 Participants
|
|
Number of sexual partners
|
1.68 number of partners
STANDARD_DEVIATION 4.32 • n=14 Participants
|
1.41 number of partners
STANDARD_DEVIATION 2.98 • n=34 Participants
|
1.55 number of partners
STANDARD_DEVIATION 3.70 • n=69 Participants
|
|
Number of condomless events
|
1.45 number of events
STANDARD_DEVIATION 4.37 • n=14 Participants
|
1.21 number of events
STANDARD_DEVIATION 2.97 • n=34 Participants
|
1.33 number of events
STANDARD_DEVIATION 3.73 • n=69 Participants
|
|
Any Sexually Transmitted Infections (STIs)
|
3 Participants
n=14 Participants
|
4 Participants
n=34 Participants
|
7 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Past 7 days, weekly for 12 weeks (e.g., Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12)Binge-drinking (five or more drinks on a single occasion for men; four or more drinks for women)
Outcome measures
| Measure |
Kudzu
n=60 Participants
Standardized kudzu, 2 grams
|
Control
n=60 Participants
Placebo, 2 grams
|
|---|---|---|
|
Number of Binge Drinking Days
Week 0
|
2.15 number of days
Standard Deviation 1.95
|
2.15 number of days
Standard Deviation 1.90
|
|
Number of Binge Drinking Days
Week 1
|
1.94 number of days
Standard Deviation 1.86
|
2.21 number of days
Standard Deviation 1.74
|
|
Number of Binge Drinking Days
Week 2
|
2.07 number of days
Standard Deviation 2.06
|
1.90 number of days
Standard Deviation 1.61
|
|
Number of Binge Drinking Days
Week 3
|
2.46 number of days
Standard Deviation 2.14
|
2 number of days
Standard Deviation 1.80
|
|
Number of Binge Drinking Days
Week 4
|
2.11 number of days
Standard Deviation 2.21
|
2.19 number of days
Standard Deviation 1.73
|
|
Number of Binge Drinking Days
Week 5
|
1.90 number of days
Standard Deviation 2.03
|
1.8 number of days
Standard Deviation 1.69
|
|
Number of Binge Drinking Days
Week 6
|
1.71 number of days
Standard Deviation 1.84
|
1.59 number of days
Standard Deviation 1.73
|
|
Number of Binge Drinking Days
Week 7
|
1.46 number of days
Standard Deviation 1.95
|
1.96 number of days
Standard Deviation 1.98
|
|
Number of Binge Drinking Days
Week 8
|
1.63 number of days
Standard Deviation 1.85
|
2.06 number of days
Standard Deviation 2.07
|
|
Number of Binge Drinking Days
Week 9
|
1.78 number of days
Standard Deviation 2.16
|
2.25 number of days
Standard Deviation 2.14
|
|
Number of Binge Drinking Days
Week 10
|
1.54 number of days
Standard Deviation 1.97
|
1.87 number of days
Standard Deviation 1.93
|
|
Number of Binge Drinking Days
Week 11
|
1.72 number of days
Standard Deviation 2.01
|
1.93 number of days
Standard Deviation 1.94
|
|
Number of Binge Drinking Days
Week 12
|
1.42 number of days
Standard Deviation 1.79
|
2.06 number of days
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 7 daysUrine samples will be collected weekly and tested for ethyl glucuronide (EtG) to determine recent alcohol consumption in the past three days.
Outcome measures
| Measure |
Kudzu
n=49 Participants
Standardized kudzu, 2 grams
|
Control
n=51 Participants
Placebo, 2 grams
|
|---|---|---|
|
Number of Participants With Ethyl Glucuronide (EtG) Positive Urine Samples
|
29 Participants
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysSelf-reported sexual intercourse partners
Outcome measures
| Measure |
Kudzu
n=52 Participants
Standardized kudzu, 2 grams
|
Control
n=53 Participants
Placebo, 2 grams
|
|---|---|---|
|
Number of Sexual Intercourse Partners
|
.94 number of partners
Standard Deviation 2.87
|
1.17 number of partners
Standard Deviation 2.89
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysSelf-reported of condomless sexual intercourse events
Outcome measures
| Measure |
Kudzu
n=52 Participants
Standardized kudzu, 2 grams
|
Control
n=53 Participants
Placebo, 2 grams
|
|---|---|---|
|
Number of Condomless Sexual Intercourse Events
|
.88 number of events
Standard Deviation 3.03
|
1 number of events
Standard Deviation 2.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysall 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
Outcome measures
| Measure |
Kudzu
n=44 Participants
Standardized kudzu, 2 grams
|
Control
n=42 Participants
Placebo, 2 grams
|
|---|---|---|
|
Number of Participants Testing Positive of Sexually Transmitted Diseases
|
4 Participants
|
2 Participants
|
Adverse Events
Kudzu
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Kudzu
n=60 participants at risk
Standardized kudzu, 2 grams
|
Control
n=60 participants at risk
Placebo, 2 grams
|
|---|---|---|
|
Cardiac disorders
Myocarditis requiring hospitalization
|
1.7%
1/60 • 3 months
|
0.00%
0/60 • 3 months
|
Other adverse events
| Measure |
Kudzu
n=60 participants at risk
Standardized kudzu, 2 grams
|
Control
n=60 participants at risk
Placebo, 2 grams
|
|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
15.0%
9/60 • 3 months
|
10.0%
6/60 • 3 months
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
8.3%
5/60 • 3 months
|
11.7%
7/60 • 3 months
|
|
Nervous system disorders
Dizziness
|
8.3%
5/60 • 3 months
|
6.7%
4/60 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
11.7%
7/60 • 3 months
|
3.3%
2/60 • 3 months
|
|
Nervous system disorders
Headache(s)
|
3.3%
2/60 • 3 months
|
10.0%
6/60 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
5/60 • 3 months
|
1.7%
1/60 • 3 months
|
|
Gastrointestinal disorders
gastrointestinal signs and symptoms, not elsewhere classified
|
3.3%
2/60 • 3 months
|
5.0%
3/60 • 3 months
|
|
Hepatobiliary disorders
Increased alanine aminotransferase (ALT)
|
3.3%
2/60 • 3 months
|
5.0%
3/60 • 3 months
|
|
Hepatobiliary disorders
increased aspartate transaminase (AST)
|
1.7%
1/60 • 3 months
|
6.7%
4/60 • 3 months
|
Additional Information
Glenn-Milo Santos, Professor
University of California San Francisco
Phone: (415) 476-1435
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place