NIH – Registry of Medical Cannabis Use and Health Outcomes (UM1 – Clinical Trial Optional)

June 24, 2022 by dld5dt@virginia.edu

Purpose:

The National Institute on Drug Abuse (NIDA) seeks applications to develop and maintain a medicinal cannabis use registry to assess the medical conditions reported as reasons for using medicinal cannabis, how and what products are being used, and the associated medical outcomes. The goal of this registry is to inform research, policy, and clinical recommendation practices on medicinal cannabis, associated conditions, and outcomes.

Background:

As of January 2022, 37 US states, four territories, and the District of Columbia allow for the medical use of cannabis products. While states with medical cannabis laws generally have some form of patient registry, there is great heterogeneity of conditions from state to state for which patients can request a card, ranging from neurological disorders such as Alzheimer’s disease, to respiratory disorders such as asthma, to gastrointestinal disorders such as Crohn’s disease. Adding to the complexity, many individuals report relief of seizures, chronic pain, insomnia, and depression and many other symptoms after using cannabis. Due to the heterogeneity across states for nearly every aspect of their medical cannabis laws, these small pockets of collected information therefore may not be comparable, standardized, or useful in understanding broader cannabis use related health outcomes. Current evidence from global database registries and other patient reported outcomes incorporates information from thousands of patients, but much of the evidence is based on anecdotal reports rather than possessing the robustness of randomized clinical trials, two sources which may produce quite different results. In addition, the evidence that medicinal cannabis use leads to a reduction in the use of prescription medications or other substances is equivocal. For example, some studies indicated that chronic prescription opioid use decreases after cannabis use, while others show no changes in opioid medication use. As many patients are already using cannabis products for medicinal applications, it is important to identify the evidence that exists and as it evolves, and to harmonize and coordinate this information to maximize the potential benefits to patients, while minimizing harmful effects.

Another challenge is that the cannabis products themselves are subject to varied and not well-enforced labeling policies. Therefore, there is a need to gather information on the products used for medicinal purposes. States that have legal adult use cannabis in addition to medical cannabis laws have encouraged safer consumption through access to regulated markets. However, sales are still occurring through unregulated channels, largely in response to price to avoid reducing consumption altogether. Consequently, we need a better understanding of where individuals are obtaining their products and whether these products are part of the local regulated market.

A 2017 National Academies of Science, Engineering and Medicine report, included several recommendations “to address research gaps, improve research quality, improve surveillance capacity, and address research barriers” as related to medical use of cannabis. One of these recommendations is to develop an evidence base on the short- and long-term beneficial and harmful effects of cannabis use. While more states allow medical use of cannabis than allow adult use, recent studies indicate that medical cannabis enrollment decreased in states with adult use laws. In addition, the number of older medical cannabis cardholders is increasing. Together, these and other phenomena highlight the need for gathering information from a diverse group of individuals that are enrolled in state medical cannabis programs, as well as those that are not enrolled in formal program but may be using cannabis for medicinal reasons.

Key Dates:

Open Date (Earliest Submission Date): October 15, 2022
Letter of Intent Due Date(s): October 15, 2022
Applications Due: November 15, 2022

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-23-011.html

Filed Under: Funding Opportunities