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Alkontrol-herbal Effects on Alcohol Drinking (Alkontrol)

Primary Purpose

Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
kudzu extract, puerarin
Placebo control
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Treatment, Alkontrol-herbal

Placebo Control

Arm Description

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.

Matched dextran containing capsules will serve as placebo.

Outcomes

Primary Outcome Measures

percent days abstinent
percent days abstinent from alcohol
drinks/day
number of alcoholic drinks/day reported
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days
percent days abstinent
percent days abstinent from alcohol
drinks/day
number of alcoholic drinks/day reported
number (or percent) of heavy drinking days
number (or percent) of heavy drinking days

Secondary Outcome Measures

Full Information

First Posted
March 11, 2017
Last Updated
July 28, 2020
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03099590
Brief Title
Alkontrol-herbal Effects on Alcohol Drinking
Acronym
Alkontrol
Official Title
Alkontrol-herbal (Isoflavone) Effects on Alcohol Drinking in an Outpatient Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.
Masking
ParticipantCare Provider
Masking Description
Neither the participants nor the study personnel providing the care/assessments will know whether the treatment received is active or placebo
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment, Alkontrol-herbal
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Matched dextran containing capsules will serve as placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
kudzu extract, puerarin
Other Intervention Name(s)
Alkontrol-herbal
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo control
Intervention Description
Matched sugar beet placebo capsules will serve as placebo.
Primary Outcome Measure Information:
Title
percent days abstinent
Description
percent days abstinent from alcohol
Time Frame
change from baseline to post 8 weeks of treatment
Title
drinks/day
Description
number of alcoholic drinks/day reported
Time Frame
change from baseline to post 8 weeks of treatment
Title
number (or percent) of heavy drinking days
Description
number (or percent) of heavy drinking days
Time Frame
change from baseline to post 8 weeks of treatment
Title
percent days abstinent
Description
percent days abstinent from alcohol
Time Frame
change from baseline to 4 weeks follow-up post-treatment
Title
drinks/day
Description
number of alcoholic drinks/day reported
Time Frame
change from baseline to 4 weeks follow-up post-treatment
Title
number (or percent) of heavy drinking days
Description
number (or percent) of heavy drinking days
Time Frame
change from baseline to 4 weeks follow-up post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Alkontrol-herbal Effects on Alcohol Drinking

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