Alkontrol-herbal Effects on Alcohol Drinking

NCT03099590 | Completed Phase 2 DMC

• 1 other identifier: 2017P000109
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Use Disorder; Alcohol Abstinence

Outcome Measures

Primary Outcomes (6)

• percent days abstinent

  percent days abstinent from alcohol

  change from baseline to post 8 weeks of treatment

• drinks/day

  number of alcoholic drinks/day reported

  change from baseline to post 8 weeks of treatment

• number (or percent) of heavy drinking days

  number (or percent) of heavy drinking days

  change from baseline to post 8 weeks of treatment

• percent days abstinent

  percent days abstinent from alcohol

  change from baseline to 4 weeks follow-up post-treatment

• drinks/day

  number of alcoholic drinks/day reported

  change from baseline to 4 weeks follow-up post-treatment

• number (or percent) of heavy drinking days

  number (or percent) of heavy drinking days

  change from baseline to 4 weeks follow-up post-treatment

Study Arms (2)

Active Treatment, Alkontrol-herbal

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

Matched dextran containing capsules will serve as placebo.

Dietary Supplement: Placebo control

Interventions

kudzu extract, puerarin DIETARY_SUPPLEMENT

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.

Also known as: Alkontrol-herbal

Active Treatment, Alkontrol-herbal

Placebo control DIETARY_SUPPLEMENT

Matched sugar beet placebo capsules will serve as placebo.

Placebo Control

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism; Alcohol Abstinence

Interventions

puerarin

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the participants nor the study personnel providing the care/assessments will know whether the treatment received is active or placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - McLean Imaging Center

Model Details: Half of the enrolled subjects will receive treatment with Alkontrol-herbal, kudzu extract, and half will receive a placebo control.

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: April 4, 2017
• Study Start: January 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)