Alkontrol-herbal Effects on Alcohol Drinking (Alkontrol)

• ClinicalTrials.gov Identifier: NCT03099590
• Recruitment Status: Recruiting
• First Posted: April 4, 2017
• Last Update Posted: March 6, 2019
• Sponsor: Mclean Hospital
• Information provided by (Responsible Party): Scott Lukas, Mclean Hospital

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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)

Contacts and Locations

Contacts

Contact: Scott E Lukas, PhD; 617-855-2767; slukas@mclean.harvard.edu

Contact: Wendy Tartarini, MA; 617-855-2174; Wtartarini@mclean.harvard.edu

Locations

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

More Information

• 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
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alcoholism; Alcohol Drinking; Alcohol Abstinence; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Puerarin; Vasodilator Agents