Federal Regulation Interferes with Cannabis Clinical Trials for Multiple Sclerosis

Without a special license, researchers can only conduct observational studies that include cannabis.

In the United States alone, approximately 400,000 Americans have multiple sclerosis (MS). These patients face balance disorders, cognitive dysfunction, fatigue, pain, and muscle weakness.

Within the United States, Colorado has the highest number of patients with MS. There are 1 in 550 people living in Colorado with the disease, compared with 1 in 750 across the country, according to a press release from Colorado State University.

Current treatments are ineffective for many patients with MS, and these individuals seek alternative treatments, including cannabis.

Previous studies have found a link between cannabis and treatment of pain and muscle spasticity. Other research shows a link between cannabis use and improvements in fatigue, muscle weakness, anxiety, and sleep deprivation, but these findings have yet to be proven scientifically. The investigators said these findings have not been verified due to strict federal regulations.

To build upon this association, researchers at the Integrative Neurophysiology Laboratory at the university are now assessing patients with MS who already use medical cannabis to determine which symptoms the treatment can improve, according to the press release.

While cannabis contains more than 100 compounds, THC and cannabidiol (CBD) are thought to be the most effective compounds for medical treatments. However, it is currently unknown what the most effective THC-CBD ration is, which type of ingestion is the most effective, or how often it should be used.

Cannabis is classified as a schedule 1 substance, which means that it has no accepted medical use, and can be abused easily. This makes cannabis difficult to study in clinical trials, and requires a license to conduct non-observational studies, according to the press release.

Even in states such as Colorado where medical marijuana is legal, physicians cannot prescribe the drug, but have to provide patients with a recommendation that can be approved or denied by the state. With scientific evidence lacking, patients must choose the strain and dosage of cannabis, since physicians cannot provide recommendations, the university reported.

The investigators are currently only performing observational studies due to federal regulations that require labs to have a special license to conduct clinical trials of cannabis, which they have applied for. The researchers conducted a survey about what types, how often, and how long patients used cannabis products, which included 139 patients with MS.

The researchers found that 66% of patients reported using cannabis, and 56% reported smoking or eating cannabis products. According to the press release, 78% of patients reported that they reduced or stopped taking other drugs due to improvements resulting from cannabis use.

The survey participants reported lower disability scores, and were less likely to be obese. While these findings are significant, longer clinical trials are needed.

The investigators are also conducting another study on the effects of cannabis use on physical function and activity level in patients with MS, according to the press release. No previous studies have been conducted to measure motor function in patients with MS who are using cannabis for treatment.

Preliminary findings suggest that patients with MS who are using cannabis have increased levels of physical activity, leg strength, and walking speed. These patients were also observed to have less muscle spasticity, fatigue, and risk of falling, according to the university.

Cannabis users were not observed to perform worse on any measurements compared with patients taking other treatments. The investigators expect positive overall results at the conclusion of the study.

Findings from observational studies can be significant, but clinical trials are crucial for advancing cannabis research since these trials are better suited to show the benefits and risks of cannabis use.

Applying for a license to conduct clinical trials of a schedule 1 substance can be complicated, resulting in few studies being approved and conducted, thus hindering progress. Many researchers are seeking to explore cannabis-related research outside of the United States where regulations are not as strict regarding cannabis, according to the press release.

The researchers hope to conduct clinical trials to better understand which products, dosage, and form are the most effective in treating patients with MS. They also aim to determine if long-term use is safe, and if tolerance changes the efficacy.

If studies can provide clinical evidence that cannabis can effectively treat patients with MS, it could establish the medicinal value of the drug. These findings may then make the case for rescheduling cannabis, and make it easier for researchers to further determine the drug’s value, the press release concluded.