Alkontrol-herbal Effects on Alcohol Drinking (Alkontrol)
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|ClinicalTrials.gov Identifier: NCT03099590|
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking Alcohol Use Disorder Alcohol Abstinence||Dietary Supplement: kudzu extract, puerarin Dietary Supplement: Placebo control||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||Neither the participants nor the study personnel providing the care/assessments will know whether the treatment received is active or placebo|
|Official Title:||Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||March 1, 2020|
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.
Dietary Supplement: kudzu extract, puerarin
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 Name: Alkontrol-herbal
Placebo Comparator: Placebo Control
Matched dextran containing capsules will serve as placebo.
Dietary Supplement: Placebo control
Matched sugar beet placebo capsules will serve as placebo.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099590
|Contact: Scott E Lukas, PhDemail@example.com|
|Contact: Wendy Tartarini, MA||617-855-2174||Wtartarini@mclean.harvard.edu|
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Contact: Scott E Lukas, PhD 617-855-2767 Slukas@mclean.harvard.edu|
|Contact: Wendy Tartarini, MA 617-855-2174 Wtartarini@mclean.harvard.edu|