Alkontrol-herbal Effects on Alcohol Drinking

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Drinking, Alcohol Use Disorder, Alcohol Abstinence

In brief

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.

Key facts

Study ID

NCT03099590

Run by

Mclean Hospital

People needed

28

Starts

2018-01-01

Expected to finish

2020-07-01

Last updated by the study team

2020-07-29

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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