A Phase 1 clinical trial conducted at the Hadassah University Hospital-Ein Kerem showed that ingesting one dose of a new slow release Metadoxine formula before consuming alcohol lowered the level of alcohol in the blood, dramatically improved motor and cognitive functions and decreased the craving for alcohol in the test participants. Metadoxine, a substance currently used to treat alcoholic addiction, is only effective for about 50 minutes. The slow release formula was developed by Alcobra Ltd., an Israeli start-up company.
The clinical trials were conducted by researchers from Hadassah’s Liver Unit and Department of Psychiatry. Dr. Meir Mizrahi and Dr. Gadi Lalazar of Hadassah’s Department of Internal Medicine A who headed the research team, presented their findings today at the annual conference of the American Association for the Study of Liver Diseases (AASLD) in Boston. More than 7,000 researchers from 55 countries attend the conference. 8 Hadassah doctors will present there 14 of their works.
After a 10-hour fast, the six participants in the first phase of the clinical trial took one dose of the slow release Metadoxine formula (1,190 – 2,100 ml.) and then drank 70 ml. of alchohol. During the 12 hour follow up/observation period, blood was drawn for alcohol and Metadoxine levels, and the subjects were graded on a driving simulator, continuous performance test used to diagnose ADHD), memory and cognitive skills. They also answered a questionnaire regarding their level of craving for alcohol.
All of participants had a decreased blood level of alcohol and the results of their motor and cognitive tests were positive; none of the them developed any related side effects.
The researchers believe that slow release Metadoxine formula can assist in the treatment of alcoholism and its side effects. They are planning to enlarge the scope of their study in the next phase of their trial in the coming months.
The Hadassah-Alcobra project is being conducted under the auspices of Hadasit, Hadassah's technology transfer company.
Alcobra Ltd. was established by Dr. Dalia Megido and Uri Gilboa in April 2008. Rina Yamin is CEO of Alcobra Ltd. (Email: rina@alcobra-pharma.com)