A Phase 2 interventional study of kudzu extract, puerarin and Placebo control in Alcohol Drinking, Alcohol Use Disorder and Alcohol Abstinence, sponsored by Mclean Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Mclean Hospital · Phase 2, Interventional, and Treatment
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 28 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Matched dextran containing capsules will serve as placebo.
Dietary Supplement: Placebo control
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.
Also known as: Alkontrol-herbal
Matched sugar beet placebo capsules will serve as placebo.
percent days abstinent
percent days abstinent from alcohol
Time frame: change from baseline to post 8 weeks of treatment
drinks/day
number of alcoholic drinks/day reported
Time frame: change from baseline to post 8 weeks of treatment
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days
Time frame: change from baseline to post 8 weeks of treatment
percent days abstinent
percent days abstinent from alcohol
Time frame: change from baseline to 4 weeks follow-up post-treatment
drinks/day
number of alcoholic drinks/day reported
Time frame: change from baseline to 4 weeks follow-up post-treatment
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days
Time frame: change from baseline to 4 weeks follow-up post-treatment
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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