Vince & Associates will conduct an inpatient clinical trial on the psychological effects of an active ingredient in marijuana—cannabidiol—in support of a federal collaboration seeking to better understand the abuse potential of the substance.
Vince & Associates was awarded a research subcontract valued at $2.8 million from Leidos Biomedical Research, prime contractor for the government-sponsored Frederick National Laboratory for Cancer Research in Frederick, Md., which is administering the effort. Funding for the project comes from the National Institute on Drug Abuse (NIDA), part of the NIH.
NIDA and NIH’s National Center for Advancing Translational Sciences (NCATS), in collaboration with the Center for Drug Evaluation and Research at the FDA, collaborated to initiate the study to evaluate the abuse potential of cannabidiol (CBD), one of the more than 80 active cannabinoid chemicals found in the marijuana plant.
The study findings will be used to add to the body of scientific evidence related to the abuse potential effects of CBD in humans and to inform scheduling decisions under the Controlled Substances Act.
Vince & Associates will be conducting a protocol for a human abuse potential study to evaluate the subjective and physiological effects of CBD compared to delta-9-tetrahydrocannabinol (delta-9-THC, the main psychoactive ingredient in marijuana), alprazolam (a central nervous system depressant), and placebo in an inpatient setting.
“We believe that this award is a testament to the clinical expertise and operational excellence of our company. We are proud to contribute to this research project,” said Dr. Brad Vince, CEO and Medical Director at Vince & Associates Clinical Research.
This research subcontract further cements the long-standing relationship Vince & Associates has with NIDA and the FDA. They were first awarded a nearly $10-million, multi-year contract in 2012 to conduct clinical pharmacology studies to support the development of new medications for the treatment of substance use disorders; then, a $5-million, five-year contract with the CDER-FDA to conduct bioequivalence studies of innovator and generic drugs, such as anti-epileptic drugs. In October 2015, Vince & Associates was awarded a contract with the FDA’s Office of Generic Drugs to conduct a clinical pharmacology pharmacokinetic (PK) study of opioids manipulated via milling procedures.