Clinical Trial: Alkontrol-herbal Effects on Alcohol Drinking

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.

Sponsor: Mclean Hospital

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mclean Hospital

Dates:
Date Received: March 11, 2017
Date Started: April 15, 2017
Date Completion: March 1, 2020
Last Updated: March 28, 2017
Last Verified: March 2017