Clinical trials

Clinical trials

Researchers at the Institute for Drug and Alcohol Studies at Virginia Commonwealth University oversee preclinical and early clinical trials through the VCU Center for Medication Development for Cocaine Use Disorder.

The medication development center was created by a five-year, $6 million grant that includes clinical trials designed to guide decisions on moving forward with more expensive large-scale clinical trials. F. Gerard Moeller, M.D., director of IDAS, is the grant’s principal investigator.

Currently, no approved medication exists for cocaine addiction despite 30 years of research. 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. The grant includes the following components:

Medication safety

Researchers will examine the safety of new medications in a controlled clinical research environment at the VCU Center for Clinical and Translational Research. The project is led by Moeller.

Brain imaging

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. The project is led by Joel Steinberg, M.D., professor in the VCU School of Medicine’s Department of Psychiatry.

Preclinical trials

Preclinical trials will examine effects of potential medications on cocaine use, on responses to drug-related cues and on impulsivity. The project is 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.

Educational core

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 core is led by William Dewey, Ph.D., chair of the VCU School of Medicine’s Department of Pharmacology and Toxicology.

* The new center is supported by National Institute on Drug Abuse grant No. U54 DA38999.