On February 13, 2025, the Drug Enforcement Administration (DEA) published a notice in the Federal Register regarding the University of Kentucky Cannabis Center’s application to become a bulk manufacturer of marijuana for research purposes. This action initiated a 60-day comment period, set to conclude on April 14, 2025, during which other registered manufacturers or applicants could submit comments or objections.
The application by the University of Kentucky Cannabis Center, submitted on July 1, 2024, sought authorization to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA-registered researchers. The DEA indicated that the application would be evaluated based on the criteria outlined in 21 U.S.C. 823(a) and in accordance with the rule published on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318. The DEA also specified that this registration, if granted, would not permit activities beyond those explicitly authorized by DEA regulations.
During the DEA’s evaluation, the UK Cannabis Center was actively involved in various research projects, including:
• Clinical Trials:
◦ Cancer Trial: A double-blind, placebo-controlled, randomized trial in collaboration with the UK Markey Cancer Center investigating the use of cannabis in cancer patients. The trial experienced delays with drug supply but secured a new supplier.
◦ Obesity and Metabolic Health Trial: A double-blind, placebo-controlled, randomized trial in partnership with the UK Barnstable Brown Diabetes Center and the division of endocrinology, studying the effects of daily oral cannabis doses on patients with pre-diabetes and obesity. This trial also faced drug supply delays.
◦ NIH Funded Trials: The center was also engaged in NIH-funded research on the effects of cannabis on outcomes related to opioid use disorder, including studies on the abuse potential of cannabis alone and in combination with opioids.
• Pilot Projects: The Center had pilot projects underway funded by $380,000, focusing on diverse areas including cannabis consumption using traffic fatality data, the impact of cannabis laws on opioid and benzodiazepine prescriptions, and perinatal cannabis use.
• Growing Facility: The center was working to establish an indoor growing facility and was preparing a DEA Schedule I growing application.
The University of Kentucky Cannabis Center aimed to be among a few centers in the country capable of conducting clinical trials with controlled cannabis doses. The center was seeking to explore the therapeutic benefits of cannabis for various medical conditions, determine effective dose regimens, and address health issues relevant to the citizens of Kentucky, such as cancer, obesity, and opioid use disorder.
