Alcohol ConsumptionPhase 2/3Kudzu MRSNCT01739842
Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
A Phase 2/3 study testing Kudzu extract in people with Alcohol Consumption and Cerebral Blood Flow, run by Mclean Hospital.
Trial summary
This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS). 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, Cerebral Blood Flow
- What is being tested?
- Kudzu extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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, no psychopathologies)
- Body Mass Index between 18-30, inclusive
- Age 21-40 years
- Moderate alcohol drinkers (less than 20 drinks/week)
- Have a stable living situation with current postal address
- No contraindications to MR scanning (see MR scanning exclusion criteria below)
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.
- 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.
- Maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions.
Show all 10Show fewer
- Tobacco use greater than 10 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)
- For female volunteers, a positive pregnancy test
About this study
This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
- Conditions
- Alcohol Consumption, Cerebral Blood Flow
- Being tested
- Kudzu extract
- Keywords
- Alcohol consumption, Kudzu extract, Cerebral blood flow
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kudzu extractDietary supplement
Also called Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal®
| Study group | Role | What they receive |
|---|---|---|
| Kudzu extract treatment | Active comparator | Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session.
During the medication week, participants will take 2 capsules three times a day for a total dose of 3 grams of kudzu. Receives: Dietary Supplement: Kudzu extract |
| Placebo | Placebo comparator | Placebo will be administered as a pretreatment 2 ½ hours before a drinking session.
During the medication week, participants will take 2 capsules three times a day. Receives: Dietary Supplement: Kudzu extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate at which alcohol enters the brain
To determine the effects of kudzu extract treatment on the rate at which alcohol enters the brain and to determine if this is due to a change in cerebral blood flow as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
Measured: 2.5 hours after drug administration
Secondary outcomes (1)
Impact of alcohol and kudzu on resting state networks (RSN).
Measured: 2.5 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionOct 2015
Why it stopped: Funding was not received for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739842
- Sponsor's protocol ID
- 2012-P-001780
- Other IDs
- AA10536
- Acronym
- Kudzu MRS
- Status last verified
- Oct 2015
- First submitted
- 13 Nov 2012
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kudzu Effects on Brain Ethanol Levels: Proton Spectroscopy Assessment
- ClinicalTrials.gov ID
- NCT01739842
- Acronym / sponsor ID
- Kudzu MRS / 2012-P-001780
- Conditions
- Alcohol Consumption, Cerebral Blood Flow
- Keywords
- Alcohol consumption, Kudzu extract, Cerebral blood flow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not received for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kudzu extract treatment | Active comparator | Dietary Supplement: Kudzu extractKudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day for a total dose of 3 grams of kudzu. |
| Placebo | Placebo comparator | Dietary Supplement: Kudzu extractPlacebo will be administered as a pretreatment 2 ½ hours before a drinking session. During the medication week, participants will take 2 capsules three times a day. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of understanding and complying with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, no psychopathologies)
- Body Mass Index between 18-30, inclusive
- Age 21-40 years
- Moderate alcohol drinkers (less than 20 drinks/week)
Key exclusion criteria (10 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.
- 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.
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 |
|---|---|---|
| Kudzu extractAlso: Kudzu root extract (NPI-031), Puerariae lobata, Alkontrol-Herbal® | Dietary supplement | Kudzu extract treatment, Placebo |
Primary outcome
Rate at which alcohol enters the brain
Time frame: 2.5 hours after drug administration
To determine the effects of kudzu extract treatment on the rate at which alcohol enters the brain and to determine if this is due to a change in cerebral blood flow as measured by rapid proton magnetic resonance spectroscopy (1H-MRS).
1 secondary outcome
Impact of alcohol and kudzu on resting state networks (RSN).
Time frame: 2.5 hours after drug administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Kudzu extract in people with Alcohol Consumption and Cerebral Blood Flow, run by Mclean Hospital.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate at which alcohol enters the brain (time frame: 2.5 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2015.