Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alkontrol-herbal Effects on Alcohol Drinking (Alkontrol)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099590
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE March 11, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date July 29, 2020
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alkontrol-herbal Effects on Alcohol Drinking
Official Title  ICMJE Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Alcohol Drinking
  • Alcohol Use Disorder
  • Alcohol Abstinence
Intervention  ICMJE
  • 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
  • Dietary Supplement: Placebo control
    Matched sugar beet placebo capsules will serve as placebo.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: kudzu extract, puerarin
  • Placebo Comparator: Placebo Control
    Matched dextran containing capsules will serve as placebo.
    Intervention: Dietary Supplement: Placebo control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2020)
28
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
40
Actual Study Completion Date  ICMJE July 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099590
Other Study ID Numbers  ICMJE 2017P000109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Scott Lukas, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mclean Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP