Alcohol use disorders constitute a major unmet medical need — affecting 18 million people and causing 100,000 annual deaths in the United States — and current therapeutic approaches have had only limited and nondurable success in treating them.
Daryl Davies, associate professor at the USC School of Pharmacy, hopes to develop an effective treatment for these disorders through two new studies, one focusing on repurposing the Federal Drug and Administration-approved drug ivermectin — currently used as an antiparasitic medication — and the other examining the role of specific receptors on alcohol intake. His novel approaches to dealing with alcohol use disorders have earned him a wide range of new funding.
This includes financial support from the Southern California Clinical and Translational Science Institute (SC CTSI) at USC and Childrens Hospital Los Angeles, which awarded him a pilot grant for the project titled “Repositioning Ivermectin for the Treatment of Alcohol Use Disorders/First in Human Studies,” as well as a second, interrelated grant from the Clinical and Translational Science Institute at the University of California, Los Angeles (UCLA), titled “Repositioning Ivermectin for the Treatment of Alcohol Use Disorders,” which was awarded to his UCLA clinical partner, Lara Ray, for which he will serve as key personnel. The SC CTSI grant comes in the form of a $50,000 2013 Multidisciplinary Research Pilot Award, and UCLA’s grant is a $30,000 2013 Pilot Award from the Clinical Research Center.
“We recently reported that ivermectin significantly reduced alcohol intake in mice,” Davies said. “The specific aims of this multidisciplinary SC CTSI pilot project will provide key clinical and preclinical evidence that ivermectin can be repositioned as a novel therapeutic agent to treat alcohol use disorders.”
The funding will be used to enroll 10 alcohol dependent individuals into a pilot safety and efficacy trial of ivermectin.
“The SC CTSI award allows us to do a 10-person clinical trial at UCLA, while UCLA’s portion of the funding is important because it allows us to use their onsite clinical trials unit,” Davies said.
“We are excited to support this translational research. It has great potential to repurpose an existing generic medication to help treat a very common and serious problem — alcohol abuse,” said Thomas Buchanan, SC CTSI director and vice dean for research at the Keck School of Medicine of USC. “I am very happy we can work with our colleagues in the CTSI at UCLA to make this research happen.”
Ray added: “The translation of animal findings to humans is key to developing treatments that will ultimately improve the quality of life of patients suffering from alcoholism. My laboratory is committed to developing medications for addiction, and we are excited about our partnership with Dr. Davies’ group.
”The clinical study will examine the safety of combining ivermectin with moderate doses of alcohol, and it will test whether ivermectin reduces the reinforcing effects of alcohol and alcohol craving. The study also aims to set the stage for a Phase II study in which a preclinical team at USC will test the hypothesis that longer-term, oral administration of ivermectin reduces alcohol intake with tolerable and limited side effects.
Davies will collaborate with other researchers on the project. School of Pharmacy collaborators will be Ronald Alkana, Kathy Rodgers, Stan Louie and Eunjoo Pacific. At CHLA, Davies will work with Michael Neely. His UCLA collaborators include Ray, Daniel Roche and Karen Miotto.
“The use of ivermectin as a therapeutic agent to reduce alcohol consumption represents a novel use of the drug and opens an exciting new venue in the search to identify new ways to treat alcohol use disorders,” Davies said.
In addition to these awards, the National Institutes of Health recently awarded Davies a three-year grant for the project titled “Regulation of Alcohol Intake by Purinergic P2X4 Receptors.”