A Phase 2 interventional study of Kudzu and Placebo in Alcohol Consumption, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-21.
Sponsored by Mclean Hospital · Phase 2, Interventional, and Treatment
This is a study designed to test whether a single administration of kudzu extract (2 mg) will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as pretreatment 2 ½ hours before the drinking session.
In a laboratory experimental setting, subjects will be treated with placebo or 2 grams of kudzu extract 2.5 hours before an afternoon drinking session. The investigators hypothesis is that the kudzu pretreatment will reduce alcohol consumption in this free choice, self-administration paradigm.
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This study's enrollment of 20 is below the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
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This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.
Dietary Supplement: Placebo
Kudzu 2mg
Dietary Supplement: Kudzu
Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.
Also known as: Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
Drinking Behaviors
A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).
Time frame: Study end
| Milestone | Placebo | Kudzu |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).
| beers consumed | Placebo | Kudzu |
|---|---|---|
| Drinking Behaviors | 3.4 ± 1.1 | 1.9 ± 1.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/10 (0%) | 0/10 (0%) |
| Kudzu | — | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Placebo | Kudzu | Total |
|---|---|---|---|
| Mean | 24.6 ± 3.3 | 22.6 ± 3.7 | 23.6 ± 6.2 |
| Sex: Female, Male(Participants) | Placebo | Kudzu | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 10 | 10 | 20 |
| Race (NIH/OMB)(Participants) | Placebo | Kudzu | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 9 | 18 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Kudzu | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 9 | 10 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Kudzu | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Mclean Hospital