A Novel Pharmacotherapy for Alcoholism and Alcohol Liver Disease
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
It is proposed to test metadoxine (MTDX) that it is hypothesized to be significantly
beneficial for the treatment of alcoholism and ALD. Metadoxine is currently approved in
Europe for acute and chronic alcohol intoxication but has never been tested in the US.
Furthermore, MTDX is used in Europe to treat ALD. Preliminary evidence shows that MTDX
reduces alcohol consumption in AD individuals. If the role of MTDX in reducing alcohol
consumption and improve liver function is confirmed by a rigorous study design, then MTDX
might represent a truly innovative pharmacotherapy for AD, given the potential to be used for
AD individuals with ALD. However until this proposal, MTDX has never been investigated as a
treatment for AD able to reduce both alcohol consumption and improve alcohol-related liver
damage via a double-blind placebo-controlled study. This project therefore proposes to
conduct a 12-week (followed by a 3-month follow-up), double-blind, placebo-controlled,
between-subject randomized clinical trial with MTDX (500mg t.i.d.) in AD individuals.
Phase:
Phase 2
Details
Lead Sponsor:
Brown University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)