University of California Cannabis Research Workshop May 2019 Meeting Summary

Abstract

On May 30, 2019, the University of California Office of the President, in partnership with University of California, Irvine, hosted a daylong University of California Cannabis Research Workshop designed to explore ways to advance research collaborations on a range of relevant topics, develop a common understanding of the current regulatory framework for conducting cannabis-related research, and formulate next steps for facilitating synergistic cannabis research. This report provides a summary of that meeting.

On May 30, 2019, the University of California Office of the President (UCOP), in partnership with University of California, Irvine (UCI), hosted a daylong University of California (UC) Cannabis Research Workshop designed to explore ways to advance research collaborations on a range of relevant topics, develop a common understanding of the current regulatory framework for conducting cannabis-related research, and formulate next steps for facilitating synergistic cannabis research. One hundred twenty-eight people registered, including university leadership, scientific investigators, research administrators, and others across the UC.

Overview of Cannabis Laws, Regulations, and UC Policies

UCI Vice Chancellor for Research Pramod Khargonekar, PhD, commenced the workshop with opening remarks followed by Ellen Auriti, JD, Principal Counsel in the Office of General Counsel, who provided an overview of the legal context for cannabis research. She discussed the classification of cannabis as a Schedule I drug, exceptions made for parts of the cannabis plant, and the constraints placed on research due to the federal restrictions. Taken together with other laws and regulations (e.g., Drug-Free Schools and Community Act, Drug-Free Workplace Act), the legal environment creates considerable friction in the forms of delays, expenses, security, record-keeping, and federal review. Furthermore, the current legal environment limits the generalizability of research because it denies access to the wide range of products available in the real world, impedes progress using nonpsychoactive extracts such as cannabinoidal, and complicates research partnerships with cannabis industry in states that have legalized the medicinal and adult use of cannabis and related products. Finally, Auriti discussed the implications of the 2018 Farm Bill, which effectively exempts hemp and its derivatives from the Schedule I requirements for research and authorizes hemp cultivation under specific circumstances.*

Funding for Cannabis Research

Agnes Balla, Research Policy Manager in the Research Policy Analysis and Coordination office, discussed federal investment in cannabis research, including an estimated $254 million investment by the National Institutes of Health in 2017, with the National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism accounting for 60% of this investment. In California, Proposition 64, which legalized the adult use of cannabis, established new taxes that permit the state to allocate $2 million annually to University of California, San Diego (UCSD) Center for Medicinal Cannabis Research; $3 million to the California Highway Patrol to establish driving under the influence protocols; and $10 million annually for 10 years to a public university or universities, as selected by the California Bureau of Cannabis Control, to study the implementation and effect of Proposition 64. Although private industry represents another source of research funding, federal law raises barriers to research partnerships that may expose investigators and campuses to criminal charges or losses of federal funding. A UCOP pilot program has proposed a three-tiered framework when considering proposed funding from the private cannabis industry.^†

Tracy Richmond McKnight, Director of the Tobacco-Related Disease Research Program (TRDRP), provided an overview of the cannabis-related research portfolio that is supported by the TRDRP. Under Propositions 56 and 99, TRDRP receives a portion of taxes on tobacco products to support research that facilitates the elimination of smoking and tobacco use and mitigates the human and economic costs of tobacco use in California. Because cannabis and tobacco are both inhaled substances commonly used together and can similarly impact public health, some of the research that TRDRP funds has cannabis as a primary or secondary focus. Of note was the estimated $26 million portfolio of 38 grants that include research in the environmental, neuroscience, policy, and social-behavioral aspects of cannabis and related products. Key priorities for the portfolio include the adverse impact that the increasing popularity and use of cannabis has had on smoke-free laws and for renormalizing smoking and the use of tobacco products broadly.

Hemp Cultivation: Perspectives from Agriculture and Natural Resources

Wendy Powers, PhD, Associate Vice President of the UC Division of Agriculture and Natural Resources (ANR), provided an overview of ANR's interest in hemp research. She noted that ANR extension specialists and researchers at UC Berkeley, UC Riverside, and UC Davis have been working on protocols for several hemp variety trials. Funding these studies has been challenging as has finding suitable seed sources, but previous years' preparation has allowed ANR and UC Davis to be the first to start variety trials in 2019.

UC Cannabis Research Centers and Institutes

Attendees from each UC cannabis research center or institute were invited to provide brief overviews of their programs and discuss their key priorities. Following are summaries of these presentations.

Center for Medicinal Cannabis Research, UCSD

Founded in 2000 with funding from the State of California, the Center for Medicinal Cannabis Research (CMCR) represents the longest-running cannabis clinical research center in the United States. CMCR's mission is to facilitate high-quality scientific studies to ascertain the safety and efficacy of cannabis and cannabinoid products and examine alternative forms of administration. It seeks to serve as a resource for health policy planning and to educate medical professionals and the public regarding the potential of utilizing cannabis/cannabinoids as medicine. To date, it has completed eight randomized clinical trials assessing the efficacy of smoked or vaporized cannabis for treating select medical conditions and has 10 pending or active clinical trials addressing the effects of cannabis and cannabinoids on autism, essential tremor, early psychosis, bipolar disorder, and migraine, among others. CMCR also has active collaborations with the California State Highway Patrol to assess the effects of cannabis on driving performance and improve the detection of cannabis-impaired driving. In addition, with funding provided through Proposition 64, the CMCR administers a peer-reviewed cannabis research funding program to support California-based investigators conduct health-related cannabis research. For more details, see https://www.cmcr.ucsd.edu/

Cannabis Research Center, UC Berkeley

The UC Berkeley Cannabis Research Center promotes interdisciplinary scholarship on the social and environmental dimensions of cannabis production. Through scientific research and engagement with community, government, and academic entities, it advances understanding of cannabis agriculture in socioecological systems at local, national, and global scales. It seeks to inform public dialog and contribute to the development of prosperous communities and healthy environments. Its research and outreach focus on the dynamic relationships between the (1) environmental impacts of cannabis production, (2) policy and regulation, including informal systems of governance, and (3) the social, agricultural, and environmental practices of cannabis cultivators. For more information, see https://crc.berkeley.edu

Center for the Study of Cannabis, UCI

The Center for the Study of Cannabis (CSC) is a multi-disciplinary research center created by the Schools of Law and Medicine in 2017 to address the medical, legal and cultural challenges posed by cannabis legalization. CSC includes more than 20 basic science and clinical investigators and aims to fosters academic research in two areas: (1) the impact of medical and non-medical cannabis on human health; and (2) the legal landscape surrounding the production, sale, and use of cannabis-based products. Additional goals of the CSC are to: (1) engage key stakeholders at the State and national level (scientists, lawmakers, regulatory bodies, cannabis industry and lay public) in a balanced, evidence-based discourse about cannabis; (2) heighten public awareness about the potential risks and benefits of cannabis use; and, (3) disseminate the results of its academic endeavors. For more information, see http://cannabis.uci.edu/.

University of California, Los Angeles Cannabis Research Initiative, University of California, Los Angeles

The University of California, Los Angeles (UCLA) Cannabis Research Initiative (CRI) was established in 2017 and brings together more than 40 faculty members from across 18 departments. CRI's mission is to advance scientific understanding of the impact of cannabis and hemp on body, brain, and society. CRI's priorities are to study the therapeutic potential of cannabis and cannabinoids to treat chronic pain, opioid use disorders, cancer, Alzheimer's disease, and address the adverse health consequences related to cannabis use. It seeks to gather public health, criminal, and economic data from throughout the state to evaluate the effects of cannabis legalization on California. For more information, see https://www.uclahealth.org/cannabis/

UC Nicotine and Cannabis Policy Center, UC Merced

Founded in 2018, UC Merced's Nicotine and Cannabis Policy Center (NCPC) is the first cannabis research center funded by TRDRP. Its mission is to conduct tobacco and cannabis policy research, disseminate and translate results to support tobacco and cannabis control efforts, and reduce tobacco-related morbidity and mortality for 11 counties in the San Joaquin Valley and adjoining Sierra Foothills. Utilizing a community-engaged research approach, NCPC aims are to (1) establish grassroots capacity to respond to emerging tobacco and cannabis control policy needs; (2) monitor tobacco and cannabis control policy efforts in the region, document challenges to enforcing those policies, and identify emergent policy issues; (3) conduct both short- and long-term research projects that will inform tobacco and cannabis control policy at the local, state, and federal levels; and (4) establish a visible and stable presence for tobacco and cannabis control policy research and coordination in the San Joaquin Valley. NCPC's flagship research project, a wide-scale epidemiological survey of 11 counties, is underway and will be the first to provide local data on cannabis use, attitudes toward cannabis, and knowledge and support for cannabis control policies. For more information, see https://ncpc.ucmerced.edu/

Strengthening Research Synergies Across Disciplines: Research Opportunities and Collaborations Within the UC System

During the afternoon session, attendees broke into groups for a facilitated discussion of key issues. In the first session, led by Daniele Piomelli, participants discussed research priorities associated with cannabis genetics and epigenetics, molecular approaches to understand and harness its genetic diversity, as well as sustainable cultivation methods. Participants explored its potential as medicine, including the therapeutic potential of phytocannabinoids on chronic pain and opioid use, as well as the pharmacokinetics and pharmacodynamics, particularly as related to dosing and delivery modes. Others noted important research priorities related to understanding the risk to public health across the lifespan, including its use during pregnancy and breastfeeding, addictive potential, interaction with comorbid psychiatric conditions, overdose and second- or third-hand exposure. Finally, this group discussed the need to provide evidence-based regulatory policy governing adult recreational use, train the next generation of researchers and clinical and public health professionals.

A Deeper Dive into Cannabis Regulatory Requirements and UC Policies: Presentations for Research

A second concurrent session examined current issues related to regulatory requirements and UC policies for cannabis research. Participants took a deeper dive into the federal regulatory policies and requirements. Monique Skahan, UCI Controlled Substance Coordinator, presented the process for applying for and maintaining a Schedule I registration permitting research on cannabis. Participants discussed the need for standardized practices across UC governing research partnerships and regular communication around the changing regulatory landscape.

Closing Comments and Next steps

The final session of the day provided an opportunity to revisit key discussion points and, importantly, focus on next steps for a comprehensive integrated UC-wide approach to cannabis-related research. Recommendations included identifying and sharing funding opportunities, disseminating public policy papers that could inform decision-makers, and developing a system for triaging regulatory questions within and between campuses. Several participants advocated in support of centralized coordination from UCOP to ensure consistent messaging and improved coordination and collaboration.

Key action items noted for the meeting included facilitating greater information sharing between campuses, encouraging the provision of peer-to-peer support, and hosting regular interactions that might include webinars, conference calls, or online discussions among affinity groups. Outgoing Vice President of Research and Graduate Studies, Art Ellis, PhD, closed the meeting with the encouragement that researchers engage key stakeholders in research prioritization and to use personal stories to help increase awareness of, and interest in, cannabis research in highlighting both the potential benefits and risks of using cannabis and its derivatives.