About This ProjectAlcoholism and alcohol abuse affect every American – contributing to over 100,000 deaths and costing the nation $220 billion yearly. Unfortunately, there are very limited pharmacotherapies to treat alcohol abuse problems.
We believe Ivermectin, an approved drug used for other indications, can help individuals suffering from alcohol abuse. We need your support to conduct the first human efficacy study to show that IVM can be repurposed to treat alcohol use disorders.
Ask the ScientistsJoin The Discussion
What is the context of this research?
Using existing approved drugs for other indications represents a fast and economically prudent approach for drug development. Our approach is based on the premise that Ivermectin (IVM), an FDA-approved drug, can be repositioned to treat Alcohol Use Disorders (AUDs). The goal of this project is to provide key clinical evidence that IVM can be repositioned as a novel therapeutic agent to treat AUDs.
Our team at USC and UCLA think that this is a very viable approach to treating AUDs because IVM acts on many of the same targets in the brain as alcohol does. IVM also has some anxiolytic activity that may help individuals deal with anxiety as they reduce alcohol intake. Currently, some patients are prescribed drugs, such as benzodiazepines (e.g., diazepam – valium), as an ethanol replacement therapy. But this approach can only be used for a very short period of time as the patient quickly becomes addicted to these drugs. This is where IVM comes in – as our studies suggest that IVM has many of the good properties of an anxiolytic – but not the addictive properties. With the funding of this project, we can take our work from the lab bench to the next step with a first in human study that tests the effectiveness of IVM in people with AUDs.
What is the significance of this project?
About 8.5% of US adults (18 million people) suffer from alcohol use disorders (AUDs). While alcohol use in humans has been around probably since the beginning of time, we have not been successful at developing therapies for individuals that are suffering from alcohol abuse and alcoholism. In fact, even the sites and mechanism(s) of alcohol action remain poorly understood.
IVM hits multiple targets in the brain that are also known to be targets for alcohol! This is a new approach to treating alcohol abuse because IVM – competes directly with alcohol for its activity sites. Thus this drug may actually help reduce alcohol intake, in part, by blocking alcohol activity from some of the targets that it works on in the brain.
Alcohol use disorders rank third on the list of preventable causes of morbidity and mortality in the United States. The economic burden to society exceeds the costs of other leading preventable causes of death such as cigarette smoking. Thus AUDs remains a significant unmet medical need!
What are the goals of the project?
We will enroll 10 alcohol dependent subjects in a randomized, placebo-controlled safety trial testing the combination of IVM with controlled alcohol administration in individuals. This clinical study will examine the safety of combining IVM with moderate doses of alcohol and will test the effectiveness of IVM in reducing the effects of alcohol and alcohol craving in patients.
We believe whole-heartedly in the chances of our success for this project. In fact, my colleagues and I are working on this project for free. A 10 person trial that addresses the disease that we are testing typically costs at least $100K, so this is really a tremendous opportunity to make a great stride against alcoholism and alcohol abuse. This project has great potential – but we need your help.
The funds that we are attempting to raise for this project will only be used to offset a small portion of the operational costs of the study and the chemistry analysis that we need to do. These costs includes the costs of Materials and Supplies, patient recruitment, and laboratory costs. This last group of expenses (laboratory costs) is the most important as it will 1) Ensure that the patients in the study are not in any obvious health dangers before enrolling in the study and 2) provide the necessary funds required to pay for the laboratory analysis of the pharmacokinetics and pharmacodynamics of the drug as it interacts with alcohol in our patients. Finally, the patients will undergo a health physical which your contribution will help cover. If we exceed our funding goal, we would use the excess funds to increase the number of patients that we test. The chemistry work that we are doing will give us, for the first time, insight into what and how does IVM interact in humans when the patients are alcoholics and they are consuming alcohol? This is a question that has never been asked in humans. Moreover, how does the human body deal with IVM when it is given in the presence of alcohol? Are there changes in the effects of IVM in humans that we did not identify in our preclinical rodent studies? As mentioned above, the first, small trial should cost in excess of $100,000. We are going to do this work for less than half that cost. The only reason that we have this opportunity is that every member of the team is committed to seeing this project through.
Meet the Team
1990-1992 California State University, MA—Biology (Emphasis in Molecular Biology)
1987-1990 California State University, BA with Honors—Biology
Team BioDaryl L. Davies, PhD is an Associate Professor of Clinical Pharmacy at the University of Southern California (USC) School of Pharmacy. He is also the Associate Director of Education in Drug Development at the International Center of Regulatory Science at USC. Dr. Davies earned his Bachelor’s (1990) and Master’s (1992) Degrees in Biology at California State University, Dominguez Hills. His PhD training was undertaken at the Department of Molecular Pharmacology and Toxicology, USC School of Pharmacy. Dr. Davies dissertation focused on identification of critical targets (sites) of ethanol (alcohol) action in the central nervous system and how alcohol alters brain function. He was awarded his PhD from USC in 1996.
Dr. Daryl Davies
Daryl L. Davies, PhD is an Associate Professor of Clinical Pharmacy at the University of Southern California (USC) School of Pharmacy. He is also the Associate Director of Education in Drug Development at the International Center of Regulatory Science at USC. Dr. Davies earned his Bachelor’s (1990) and Master’s (1992) Degrees in Biology at California State University, Dominguez Hills. His PhD training was undertaken at the Department of Molecular Pharmacology and Toxicology, USC School of Pharmacy. Dr. Davies dissertation focused on identification of critical targets (sites) of ethanol (alcohol) action in the central nervous system and how alcohol alters brain function. He was awarded his PhD from USC in 1996.
Dr. Lara Ray
I am generally interested in the etiology and treatment of substance use disorders. My approach to clinical science involves the integration of experimental psychopathology, behavioral genetics, and pharmacology. More recently, my laboratory began using neuroimaging methods to complement our research program. Here are the various lines of research I am interested in pursuing along with representative publications. A full list of my publications and presentations can be seen in my CV here.
Dr. Kathy Rodgers
My research over the last 20 years has evaluated the ability of therapeutics to regenerate injured tissue and product development. My focus is on preclinical modeling and safety evaluation as well as interactions with the FDA and translating novel concepts to treat unmet medical needs. As a board certified toxicologist, I am excited to participate in the development of a product to reduce chronic alcohol use. I look forward to participating in insuring the safe use of IVM in this therapeutic arena.
Additional InformationI have been working on alcohol research for my entire career. I have done this because I have seen firsthand the devastation that this disease produces – the broken families, the death, the sadness. Alcoholism is a disease – and the people struggling with it are suffering from its unrelenting effects.
I believe that IVM can help. And because it’s already an approved drug for other indications, we can more quickly and economically bring it to market, making it available for the millions of individuals suffering from this disease.
This is the first step to make that goal attenable. It is my hope that you will consider helping by supporting this project that has such great life-saving potential. Thank you.
Relevant PublicationsYardley M, Wyatt L, Khoja S, Asatryan L, Ramaker MJ, Finn DA, Alkana RL, Huynh N, Louie SG, Petasis, NA, Bortolato M and Davies DL. Ivermectin Reduces Alcohol intake and preference in Mice. Neuropharmacology, 63: 190-201, 2012. PMID: 22465817
Davies DL, Bortolato M, Finn DA, Ramaker MJ, Barak S, Ron D, Liang J and Olsen RW. Recent advances in the discovery and preclinical testing of novel compounds for the prevention and/or treatment of alcohol use disorders, Alcohol Clin Exp Res, 37 (1): 8-15, 2013. PMID: 22671690
Bortolato M, Yardley M, Khoja S, Godar SC, Asatryan L, Finn DA, Huynh N, Alkana RL, Louie SG and Davies DL. Pharmacological insights into the role of P2X4 receptors in behavioral regulation: lessons from ivermectin, Int J Neuropsychopharmacology, 2012 Sep 17:1-12. [Epub ahead of print] PMID: 23174033.
Asatryan L, Popova M, Perkins DI, Trudell JR, Alkana RL and Davies DL. Ivermectin Antagonizes Ethanol Inhibition in P2X4 Receptors. J. Pharmacol. Exp. Ther. 334:720-8, 2010. PMID: 20543096
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