Alcohol DrinkingPhase 2AlkontrolNCT03099590
Alkontrol-herbal Effects on Alcohol Drinking
A Phase 2 study testing kudzu extract, puerarin in people with Alcohol Drinking and Alcohol Use Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4 weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on alcohol intake in a population seeking treatment for an alcohol use disorder. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence
- What is being tested?
- kudzu extract, puerarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Jul 2020
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject can understand and comply with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absence of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30, inclusive
- Age 21-60 years (age will be verified by driver's license or other valid form of identification)
- Meet criteria for current Moderate or Severe (4+ symptoms) Alcohol Use Disorder per the DSM-5; If attending a self-help treatment group (e.g., AA) at time of the screening visit, subject must agree to continue attending these groups for the duration of the study
- Seeking treatment for an Alcohol Use Disorder
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- Drink 20-35 (or more) drink per week
- Report drinking on 80% of days in the past 90 days
- Have a stable living situation with current postal address
Who cannot join
- Subject meets DSM-5 criteria for major depression and/or bipolar disorder, and is not medically, pharmacologically, or clinically stable. Subjects who currently meet criteria for minor depression or bipolar disorder and have been clinically stable (including medications) for the past 2 months may participate in the study, at the investigator's discretion
- Concurrent diagnosis of any other Axis I disorder, including any substance use disorder besides alcohol use disorder Maintained on an antipsychotic or anti-seizure medication; Current prescription for benzodiazepines
- Presence of neurological, infectious, or neoplastic disease or a chronic medical disorder
- Tobacco use greater than 10 cigarettes per day
- Currently abstaining from consuming alcoholic beverages longer than 10 days
- History of major head trauma resulting in cognitive impairment or history of seizure disorder
Show all 9Show fewer
- 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 (female subjects must agree to an approved method of contraception for the duration of the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting
Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4 weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on alcohol intake in a population seeking treatment for an alcohol use disorder.
Read the detailed description
Over the past 15 years, the Behavioral Psychopharmacology Research Lab at McLean Hospital has extensively studied kudzu extract and demonstrated its safety and efficacy in healthy control subjects as well as in heavy binge drinkers. The relative success of our recent outpatient trial of kudzu extract demonstrated a modest decrease in drinking, reduction in the number of heavy drinking days, and significant increase in the number of days abstinent. This suggests that Alkontrol-herbal, kudzu extract, may be a useful adjunct in treating alcohol use disorders.
Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4 weeks of follow-up) investigating the impact that Alkontrol-herbal has on alcohol intake in a population (age 21-60 years) seeking treatment for an alcohol use disorder. Participants will take 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) t.i.d.; matched sugar beet placebo capsules will serve as placebo. Subjects will come to the lab three times a week to provide urine samples that can be tested for medication compliance through a biochemical marker, acetazolamide, included in the medication capsules. Participants will record their alcohol intake through daily diaries and a wrist actigraphy device, which will also monitor their sleep/wake activity.
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence
- Being tested
- kudzu extract, puerarin, Placebo control
- Medical subject headings
- Alcohol Drinking, Alcoholism, Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kudzu extract, puerarinDietary supplement
Also called Alkontrol-herbal
Capsules containing 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) will be used, containing 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg.
Placebo controlDietary supplement
Matched sugar beet placebo capsules will serve as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment, Alkontrol-herbal | Experimental | Alkontrol-herbal, a kudzu extract which contains 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg. Receives: Dietary Supplement: kudzu extract, puerarin |
| Placebo Control | Placebo comparator | Matched dextran containing capsules will serve as placebo. Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent days abstinent
percent days abstinent from alcohol
Measured: change from baseline to post 8 weeks of treatment
drinks/day
number of alcoholic drinks/day reported
Measured: change from baseline to post 8 weeks of treatment
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days
Measured: change from baseline to post 8 weeks of treatment
percent days abstinent
percent days abstinent from alcohol
Measured: change from baseline to 4 weeks follow-up post-treatment
drinks/day
number of alcoholic drinks/day reported
Measured: change from baseline to 4 weeks follow-up post-treatment
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days
Measured: change from baseline to 4 weeks follow-up post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jan 2018
- Primary completion1 Mar 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Model description
- Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Lukas, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099590
- Sponsor's protocol ID
- 2017P000109
- Acronym
- Alkontrol
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2017
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT03099590
- Acronym / sponsor ID
- Alkontrol / 2017P000109
- Conditions
- Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4 weeks of follow-up) investigating the impact that Alkontrol-herbal (Isoflavone; Kudzu) has on alcohol intake in a population seeking treatment for an alcohol use disorder.
Detailed description
Over the past 15 years, the Behavioral Psychopharmacology Research Lab at McLean Hospital has extensively studied kudzu extract and demonstrated its safety and efficacy in healthy control subjects as well as in heavy binge drinkers. The relative success of our recent outpatient trial of kudzu extract demonstrated a modest decrease in drinking, reduction in the number of heavy drinking days, and significant increase in the number of days abstinent. This suggests that Alkontrol-herbal, kudzu extract, may be a useful adjunct in treating alcohol use disorders.
Participants will enroll in a 14-week study (2 weeks of baseline, 8 weeks of treatment, and 4 weeks of follow-up) investigating the impact that Alkontrol-herbal has on alcohol intake in a population (age 21-60 years) seeking treatment for an alcohol use disorder. Participants will take 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) t.i.d.; matched sugar beet placebo capsules will serve as placebo. Subjects will come to the lab three times a week to provide urine samples that can be tested for medication compliance through a biochemical marker, acetazolamide, included in the medication capsules. Participants will record their alcohol intake through daily diaries and a wrist actigraphy device, which will also monitor their sleep/wake activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment, Alkontrol-herbal | Experimental | Dietary Supplement: kudzu extract, puerarinAlkontrol-herbal, a kudzu extract which contains 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg. |
| Placebo Control | Placebo comparator | Dietary Supplement: Placebo controlMatched dextran containing capsules will serve as placebo. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject can understand and comply with the protocol
- Good physical and mental health (normal physical exam, ECG, blood and urine chemistries, including absence of history or laboratory evidence of diabetes)
- Body Mass Index between 18-30, inclusive
- Age 21-60 years (age will be verified by driver's license or other valid form of identification)
- Meet criteria for current Moderate or Severe (4+ symptoms) Alcohol Use Disorder per the DSM-5; If attending a self-help treatment group (e.g., AA) at time of the screening visit, subject must agree to continue attending these groups for the duration of the study
Key exclusion criteria (9 listed)
- Subject meets DSM-5 criteria for major depression and/or bipolar disorder, and is not medically, pharmacologically, or clinically stable. Subjects who currently meet criteria for minor depression or bipolar disorder and have been clinically stable (including medications) for the past 2 months may participate in the study, at the investigator's discretion
- Concurrent diagnosis of any other Axis I disorder, including any substance use disorder besides alcohol use disorder Maintained on an antipsychotic or anti-seizure medication; Current prescription for benzodiazepines
- Presence of neurological, infectious, or neoplastic disease or a chronic medical disorder
- Tobacco use greater than 10 cigarettes per day
- Currently abstaining from consuming alcoholic beverages longer than 10 days
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 extract, puerarinAlso: Alkontrol-herbalCapsules containing 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) will be used, containing 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg. | Dietary supplement | Active Treatment, Alkontrol-herbal |
| Placebo controlMatched sugar beet placebo capsules will serve as placebo. | Dietary supplement | Placebo Control |
Primary outcome
percent days abstinent
Time frame: change from baseline to post 8 weeks of treatment
percent days abstinent from alcohol
drinks/day
Time frame: change from baseline to post 8 weeks of treatment
number of alcoholic drinks/day reported
number (or percent) of heavy drinking days
Time frame: change from baseline to post 8 weeks of treatment
number (or percent) of heavy drinking days
percent days abstinent
Time frame: change from baseline to 4 weeks follow-up post-treatment
percent days abstinent from alcohol
drinks/day
Time frame: change from baseline to 4 weeks follow-up post-treatment
number of alcoholic drinks/day reported
number (or percent) of heavy drinking days
Time frame: change from baseline to 4 weeks follow-up post-treatment
number (or percent) of heavy drinking days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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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.
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 extract, puerarin in people with Alcohol Drinking and Alcohol Use Disorder, 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 9 inclusion and 9 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 29 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percent days abstinent (time frame: change from baseline to post 8 weeks of treatment). The study lists 6 primary outcomes in all. 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 29 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.