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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Control | Placebo Comparator | Matched dextran containing capsules will serve as placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kudzu extract, puerarin | Dietary Supplement | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| D064829 | Alcohol Abstinence |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| C033607 | puerarin |
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Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
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Neither the participants nor the study personnel providing the care/assessments will know whether the treatment received is active or placebo
|
|
| Placebo control | Dietary Supplement | Matched sugar beet placebo capsules will serve as placebo. |
|
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |