Breaking Down the Barriers to Cannabinoids Research

The National Center for Complementary and Integrative Health (NCCIH) released a newly published Request for Information (RFI), “Investigators’ Interests in and Barriers to Research on the Health Effects of Cannabis and its Constituents” to solicit information from the scientific research community about its interest in and barriers to research on the health effects of cannabis and its constituents.

There is growing interest among health care providers and the public in understanding the potential therapeutic uses of cannabis-related products. But that interest must be matched by research that can deepen knowledge and inform health decisions.

Research on cannabinoids is fraught with hurdles. For example, some researchers may not know how to navigate the process of securing a Schedule 1 license. Others might be hindered by the lack of broadly accepted measures for what constitutes a “dose” or modes of administration. Thus, a key step in successfully generating more scientific evidence around the potential clinical uses of cannabis products is to identify barriers to conducting research and subsequently develop approaches that can help overcome them. The RFI responses will help broaden the NCCIH’s understanding of the research infrastructure needed to foster rigorous studies and identify areas of interest within the field.

This is timely, especially given the potential role of cannabinoids in managing pain. The overreliance on opioids has created a public health crisis and incalculable losses across the nation. Driving research that could yield new, potentially safer tools that meet the needs of people who suffer from chronic pain is an essential step in addressing the problem at its root.

NCCIH’s ongoing work in cannabinoids research is an extension of its broader effort to advance the scientific understanding of whole person health, rather than focusing on singular body parts, systems, or interventions. Most research to date on cannabinoids has narrowly focused on the potential harms of tetrahydrocannabinol (THC). As a result, little is understood about the other 110 cannabinoids and 120 terpenes contained within the plant that interact with multiple body systems. Gaining new insights on their properties, used together or in isolation, as well as potential therapeutic uses will open up new directions in whole person research.

It's time to chart a path forward—one that can lead to new understanding and reveal potential novel applications for these complex compounds.

Background

Cannabis has been used medicinally for over 3,000 years. Recently, there has been growing interest from health care providers and the public in the potential medicinal properties of cannabis-related products. The U.S. Food and Drug Administration (FDA) has approved several natural and synthetic cannabinoids (dronabinol, nabilone, and Epidiolex) for treatment of specific health conditions. Additionally, 37 states and the District of Columbia have legalized cannabis use for broad medical purposes, beyond those approved by the FDA, with often inadequate scientific research to support the benefit of their intended use. As a result, there is a need to strengthen the scientific evidence underlying the clinical impact and potential harms of cannabis products for specific diseases and conditions.

The National Institutes of Health (NIH) supports rigorous investigator-initiated research on many potential therapeutic uses of cannabis and cannabis-related compounds, but there is a need to expand the number of studies and strengthen the scientific evidence related to the clinical uses of cannabis products. Some researchers have reported barriers that hinder an expansion of research. These barriers include lack of necessary experience and/or information regarding Federal/state regulatory requirements needed to conduct research on cannabis products; unforeseen costs and effort related to obtaining Federal/state licensure; availability of and access to appropriate cannabis and cannabis products/constituents; lack of validated measures of cannabis use and exposure; and inadequate scientific infrastructure to support research studies. NIH is seeking to better understand these issues and potentially develop strategies to overcome them. To that end, NIH seeks input from the research community regarding these and additional barriers, scientific interests, and needs related to therapeutic cannabis or cannabinoid research.

Information Requested

NIH is interested in gathering information about barriers, scientific interests, and needs associated with therapeutic cannabis or cannabinoid research from investigators conducting or interested in conducting research on cannabis, cannabinoid phytochemical constituents, and related compounds (synthetic compounds, terpenes, etc.). Such information will be useful to NIH as it seeks to address the research infrastructure needs and identify areas of interest within this field. Interested individuals are requested to provide responses to any of the following topics, as well as any additional ideas not included below:

1. Cannabinoid/cannabis-related research topics of interest/importance
2. Existing and desirable scientific infrastructure and capacity to conduct cannabinoid/cannabis-related research
3. Barriers to initiating and conducting cannabinoid/cannabis-related research including but not limited to the Schedule I license process
4. NIH-coordinated activities that could help expand the field of therapeutic cannabinoid/cannabis-related research
5. Methods, tools, or resources needed to increase cannabinoid/cannabis-related research, particularly:

• Strengthening the cannabinoid/cannabis research community
• Guidance and assistance on regulatory requirements
• Funding for regulatory compliance activities
• Research reagents such as marijuana varieties, strains, constituent chemotypes, or specific cannabinoids
• Standard, validated measures of use/exposure and recommended research procedures
• Information sharing

6. Access to cannabis-related information (i.e., regulatory, clinical, scientific)

How To Submit a Response

Responses will be accepted until October 15, 2022. Responses are voluntary and may be submitted anonymously.