Alcohol ConsumptionPhase 2KUDZUNCT01596231
Kudzu Treatment for Alcohol Abuse
A Phase 2 study testing Kudzu in people with Alcohol Consumption, run by Mclean Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Kudzu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding and complying with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries)
- Body Mass Index between 18-30, inclusive
- Age 21-40 years
- Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
- Have a stable living situation with current postal address
Who cannot join
- Concurrent diagnosis of Axis I disorder
- Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
- Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
- Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
- Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
- Subjects cannot use marijuana more than once a week. Marijuana abuse/dependence are acceptable if the use criteria is met.
Show all 12Show fewer
- Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
- Tobacco use greater than 5 cigarettes per day
- History of major head trauma resulting in cognitive impairment or history of seizure disorder
- Heavy caffeine use (greater than 500 mg on a regular, daily basis)
- Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3x the upper limit of normal
- For female volunteers, a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
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.
Read the detailed description
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.
- Conditions
- Alcohol Consumption
- Being tested
- Kudzu, Placebo
- Keywords
- Alcohol consumption, Kudzu extract
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KudzuDietary supplement
Also called Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®
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.
PlaceboDietary supplement
Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
| Kudzu | Active comparator | Kudzu 2mg Receives: Dietary Supplement: Kudzu |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
- Investigators
- Scott E. Lukas, Ph.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596231
- Sponsor's protocol ID
- 2010-P-001099
- Other IDs
- Grant # AA10536
- Acronym
- KUDZU
- Status last verified
- Oct 2014
- First submitted
- 9 May 2012
- Last updated
- 21 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Penetar DM, Toto LH, Lee DY, Lukas SE. A single dose of kudzu extract reduces alcohol consumption in a binge drinking paradigm. Drug Alcohol Depend. 2015 Aug 1;153:194-200. doi: 10.1016/j.drugalcdep.2015.05.025. Epub 2015 May 27.
PubMed 26048637
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isoflavone (Kudzu) Extract Effects on Alcohol Drinking: Single Dose Pretreatment Study
- ClinicalTrials.gov ID
- NCT01596231
- Acronym / sponsor ID
- KUDZU / 2010-P-001099
- Conditions
- Alcohol Consumption
- Keywords
- Alcohol consumption, Kudzu extract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Posted 21 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis 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. |
| Kudzu | Active comparator | Dietary Supplement: KudzuKudzu 2mg |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Capable of understanding and complying with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries)
- Body Mass Index between 18-30, inclusive
- Age 21-40 years
- Moderate to heavy alcohol drinkers (on the average 20+ drinks/week) or a self-reported pattern of incidences of binge drinking 2 or more times per week (4 or more alcoholic beverages in one sitting)
Key exclusion criteria (12 listed)
- Concurrent diagnosis of Axis I disorder
- Current or past alcohol dependence; may meet criteria for alcohol abuse. Other drug dependence acceptable only if greater than 3 years.
- Immediate family history pattern of alcoholism or problem drinking (parents or siblings)
- Current drug abuse (other than alcohol or marijuana abuse). Past drug abuse is acceptable.
- Subjects cannot be actively seeking treatment for any drug or alcohol dependence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KudzuAlso: Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®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. | Dietary supplement | Kudzu |
| PlaceboPlacebo will be administered as a pretreatment 2 ½ hours before a drinking session | Dietary supplement | Placebo |
Primary outcome
Drinking Behaviors
Time frame: Study end
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26048637Penetar DM, Toto LH, Lee DY, Lukas SE. A single dose of kudzu extract reduces alcohol consumption in a binge drinking paradigm. Drug Alcohol Depend. 2015 Aug 1;153:194-200. doi: 10.1016/j.drugalcdep.2015.05.025. Epub 2015 May 27.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E. Lukas, Ph.D. principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kudzu in people with Alcohol Consumption, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking Behaviors (time frame: Study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.