Science is now focusing its sights on studying essential tremors. The Center for Medicinal Cannabis Research at the University of California San Diego announced on Tuesday that plans to import two key cannabinoids, tetrahydrocannabinol, or THC, and cannabidiol, or CBD, from Tilray in British Columbia, has received approval from the Drug Enforcement Administration.
The team intends using these imported capsules to study their effectiveness in combating the tremors afflicting millions of people across the United States, particularly the elderly. Sadly, no drug exists today to treat essential tremor, a condition that causes uncontrollable shaking when moving, unlike Parkinson’s disease, which causes shaking during sleep. Sufferers cannot write, drink, eat, or even speak.
Understanding Essential Tremors
According to the International Essential Tremor Foundation, approximately 10 million people in the United States alone, and millions more around the world endure debilitating essential tremors. Most try, with very limited success, to repurpose other drugs to stop the shaking, such as blood pressure medications. Since no treatments exist for the condition, sufferers often turn to desperate measures.
Fortunately, in at least 31 states now and counting, cannabis is legal for medical use on a horde of medical conditions. However, this study will be the first of its kind for scientists in attempting to discover the potential effectiveness of using cannabis to calm essential tremor. Despite this, some people are using cannabinoid therapy to manage the issue, albeit under the guise of another qualifying condition.
Anecdotal evidence of success with CBD treatment prompted Dr. Fatta Nahab, the tremor study’s principal and neurologist at University of California San Diego, to research marijuana as a potential treatment after two of his patients improved suddenly after buying CBD online. However, approval by the U.S. Food and Drug Administration has a few stipulations for this study.
It outlined the drug formula the team can use, a CBD to THC ratio of 20:1, in order to protect participants from any impairing high it may cause. The team must also follow guidelines regarding the CBD’s purity, shelf life, toxicity, and other information. Furthermore, the study needed safety approvals from the university, and they had to convince a California research advisory panel of their plans.
Since cannabis legalization in many states, researchers still have to jump bureaucratic hoops to study marijuana, but scientific evidence is emerging in droves these days. The university needs around 20 participants for its study, which it plans to start next year. The team will use wrist devices to monitor tremors and record any changes in severity and frequency of shaking.
Although Tilray offers limited monetary backing and provides the drug for the study, it says it has no role in analyzing the results. “Essential tremor is 10 times more common than Parkinson’s and yet nobody really about essential tremor,” Nahab opined. “That we are finally getting to a potential therapeutic option in an area that is untapped is a big deal.”
Cannabis Legalization Gaining Momentum
The health benefits of cannabis are legendary already. This marks the very first time that the federal government has, in lieu of its DEA, given approval for the importation of cannabis extracts for clinical study. This promises a new pathway for scientists struggling for decades to acquire it for medical study. Because of its illegality, researchers cannot even get it from state medical pot programs.
Instead, marijuana laws mandate that research get their weed from the National Institute on Drug Abuse, or NIDA, which grows pot at the University of Mississippi. Scientists have been complaining for a long time about the challenges of getting their hands on it, as well as its limited usefulness, variety, and quality for the purposes of clinical study. However, cannabis legalization is making it more accessible.
CBD Capsule Urgency
The study team required cannabis extracts specifically in capsule form. This makes it easier to monitor doses they administer to participants, as opposed to trying to measure what they vaporize or smoke. According to Nahab, they also felt some older participants would not want to inhale it. However, NIDI does not make capsules. For this, the team spent two years jumping regulatory hoops.
The researchers had to acquire import permission to get it from Canada, where cannabis is legal federally and recreational sales will start next month. Deputy Director of NORML, or the National Organization for the Reform of Marijuana Laws, Paul Armentano, said it shows just how desperately scientists in the United States require alternative cannabis sources.
Last week, the House Judiciary Committee approved a bill requiring the Justice Department to issue another two cultivation licenses to grow weed for research purposes. “It is very telling that you have researchers in the United States willing to exert the patience and go through the regulatory hurdles to make this happen at the same time the United States has its own supply source,” Armentano said.
This is not the first time cannabis extract is imported for clinical trials. Britain-based GW Pharmaceuticals, made history by developing the first ever CBD capsule, called Epidiolex, to acquire FDA approval. The drug treats severe and rare forms of epilepsy. Although the company created the drug in-house prior to importing it into the country for testing, Tilray has other plans.
Tilray, the first cannabis company in the United States to finish an initial public stock offering, wants to develop cannabis formulations specifically according to what researchers need to study. “It is a really big milestone for Tilray and also just for the whole industry,” its director of clinical research, Catherine Jacobson, said.
According to Jacobson, “Researchers in the United States have really been limited to doing research using dried flower. We have been able to prove to the FDA that we can manufacture investigational study drugs containing cannabinoids that meet their standards.” However, both the FDA and the DEA have yet to approve any use of or import of foreign marijuana drugs for research.
Having said that, there are changes about. According to Katherine Pfaff, spokesperson for the Drug Enforcement Agency, “It is done. There are definitely situations where, when there is no source in the United States, a registrant can import a cannabis-derived drug from another country.” Therefore, the study will get its capsules and scientists can analyze the health benefits of cannabis for essential tremor.
Normally, the National Institute on Drug Abuse provides cannabis as either joints for smoking or bulk flower for vaporizing. However, it is able to source cannabis oil, as well. It intends expanding the grow facility at the University of Mississippi to handle demand for research. NIDA has a contract with the university providing for possible delivery of CBD capsules, but it has yet to do so.
We do not yet know all the health benefits of cannabis. Marijuana laws have made research restrictive and scientists are only now studying its effects on essential tremors. Those that already use it know it helps to relieve symptoms, including shaking. Now, science has only to prove what sufferers already evidence in personal testimony. The results are more than likely to be extremely positive.