Virginia Commonwealth University has received a five-year, $6 million grant for clinical research and education directed toward the identification, evaluation and development of safe and effective treatments for cocaine addiction.
The grant, which comes from the National Institutes of Health, National Institute on Drug Abuse, will create the VCU Center for Medication Development for Cocaine Use Disorder to oversee preclinical and early clinical trials that will guide decisions on moving forward with more expensive large-scale clinical trials.
Despite 30 years of research, no approved medication exists for cocaine addiction. The lack of thorough characterization of compounds prior to large-scale clinical trials has contributed to the large number of failed clinical trials for cocaine use disorder.
F. Gerard Moeller, M.D., division chair of addiction psychiatry in the VCU School of Medicine, is the grant's principal investigator.
"We believe that previous clinical trials failed because there was insufficient preclinical and early clinical evaluation to identify the best medication and the best dose of medication before drugs were taken into expensive large-scale trials," Moeller said. "By doing a critical evaluation prior to beginning clinical trials, we will increase the chance for success, and the likelihood that the medications will be approved by the Food and Drug Administration."
Moeller's team will conduct three projects and also will develop an educational component.
- Project one, led by Moeller
- Researchers will examine the safety of new medications in a controlled clinical research environment at the VCU Center for Clinical and Translational Research.
- Project two, led by Joel Stenberg, M.D., professor in the Department of Psychiatry, VCU School of Medicine
- Researchers will complete a brain imaging study at the VCU Collaborative Advanced Research Imaging facility to examine the effects of medications on cocaine users who are in residential treatment programs. While traditional brain imaging technology shows the structure of the brain, VCU's research-dedicated MRI scanner uses advanced imaging techniques to show the function of the brain and how it works when participants are introduced to stimuli.
- Project three, led by Kathryn Cunningham, Ph.D., director of the University of Texas Medical Branch Center for Addiction Research and vice chairman of the UTMB Department of Pharmacology and Toxicology.
- Preclinical trials will examine effects of potential medications on cocaine use, on responses to drug-related cues and on impulsivity.
- Educational core, led by William Dewey, chair of the Department of Pharmacology and Toxicology, VCU School of Medicine
- One of the goals of the new center is to train the next generation of translational scientists in medication development for addictions. The program emphasizes communication among researchers in preclinical settings and researchers in clinical settings to ensure that the models they use are translational from one phase to the next.
"The new center will use translational research from brain to bedside," Moeller said. "We will produce laboratory findings related to the brain and translate those findings into the best possible treatments for addiction, thus creating a strong base for final clinical trials."
Comprehensive interdisciplinary resources and infrastructure provided by VCU's Center for Clinical and Translational Research, Office of Research and Innovation and School of Medicine were vital in earning the grant.
The new center is supported by grant number U54 DA38999.