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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
Sponsor:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Use Disorder Alcohol Abstinence Dietary Supplement: kudzu extract, puerarin Dietary Supplement: Placebo control Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. percent days abstinent [ Time Frame: change from baseline to post 8 weeks of treatment ]
    percent days abstinent from alcohol

  2. drinks/day [ Time Frame: change from baseline to post 8 weeks of treatment ]
    number of alcoholic drinks/day reported

  3. 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

  4. percent days abstinent [ Time Frame: change from baseline to 4 weeks follow-up post-treatment ]
    percent days abstinent from alcohol

  5. drinks/day [ Time Frame: change from baseline to 4 weeks follow-up post-treatment ]
    number of alcoholic drinks/day reported

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Scott E Lukas, PhD 617-855-2767 slukas@mclean.harvard.edu
Contact: Wendy Tartarini, MA 617-855-2174 Wtartarini@mclean.harvard.edu

Locations
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United States, Massachusetts
McLean Hospital Recruiting
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   
Sponsors and Collaborators
Mclean Hospital

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Responsible Party: Scott Lukas, Director - McLean Imaging Center, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03099590     History of Changes
Other Study ID Numbers: 2017P000109
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol Abstinence
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Puerarin
Vasodilator Agents