Alkontrol-herbal Effects on Alcohol Drinking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting

Conditions
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Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence

Intervention / Treatment
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* Dietary Supplement: kudzu extract, puerarin
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment, Alkontrol-herbal<br>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. | Dietary Supplement: kudzu extract, puerarin<br>* 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.<br>* Other names: Alkontrol-herbal;|
| Placebo Comparator: Placebo Control<br>Matched dextran containing capsules will serve as placebo. | Dietary Supplement: Placebo control<br>* Matched sugar beet placebo capsules will serve as placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent days abstinent | percent days abstinent from alcohol | change from baseline to post 8 weeks of treatment | 
| drinks/day | number of alcoholic drinks/day reported | change from baseline to post 8 weeks of treatment | 
| number (or percent) of heavy drinking days | number (or percent) of heavy drinking days | change from baseline to post 8 weeks of treatment | 
| percent days abstinent | percent days abstinent from alcohol | change from baseline to 4 weeks follow-up post-treatment | 
| drinks/day | number of alcoholic drinks/day reported | change from baseline to 4 weeks follow-up post-treatment | 
| number (or percent) of heavy drinking days | number (or percent) of heavy drinking days | change from baseline to 4 weeks follow-up post-treatment |