- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099590
Alkontrol-herbal Effects on Alcohol Drinking (Alkontrol)
Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- McLean Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Active Treatment, Alkontrol-herbal
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.
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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.
Other Names:
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PLACEBO_COMPARATOR: Placebo Control
Matched dextran containing capsules will serve as placebo.
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Matched sugar beet placebo capsules will serve as placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percent days abstinent
Time Frame: change from baseline to post 8 weeks of treatment
|
percent days abstinent from alcohol
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change from baseline to post 8 weeks of treatment
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drinks/day
Time Frame: change from baseline to post 8 weeks of treatment
|
number of alcoholic drinks/day reported
|
change from baseline to post 8 weeks of treatment
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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
|
change from baseline to post 8 weeks of treatment
|
percent days abstinent
Time Frame: change from baseline to 4 weeks follow-up post-treatment
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percent days abstinent from alcohol
|
change from baseline to 4 weeks follow-up post-treatment
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drinks/day
Time Frame: change from baseline to 4 weeks follow-up post-treatment
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number of alcoholic drinks/day reported
|
change from baseline to 4 weeks follow-up post-treatment
|
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
|
change from baseline to 4 weeks follow-up post-treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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