Scientists in U.S. Given Approval to Import Cannabis Material From Canadian Site
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The U.S. government has broken from its usual hard-line stance on drug regulation and border control to allow a Canadian cannabis producer to import its product into the U.S. for medical research. The decision, which is the first of its kind, will allow a research group at the University of California San Diego’s Center for Medicinal Cannabis Research to access cannabis capsules produced by Tilray Inc., a cannabis research and cultivation company based in British Columbia. Researchers will use this imported cannabis to evaluate the usefulness of cannabis medicine in treating neurological tremors.
Challenges in accessing cannabis for research purposes
Under current U.S. policy, there is only one licensed cannabis provider for American cannabis research, a department within the University of Mississippi, which operates under a contract with the National Institute on Drug Abuse (NIDA). The University maintains a small crop of cannabis on behalf of NIDA that is grown and harvested in order to fill the demand from research projects that have been granted approval by the U.S. Food and Drug Administration (FDA) or the National Institutes of Health (NIH).
Questions have been raised about whether the quality of this governmental cannabis is suitable for use in research. Recently, there has been at least one high-profile case where a shipment of government cannabis was found to contain excessive cannabis leaf and stem matter (which is not typically used in cannabis consumption or scientific study) and some traces of mold on the cannabis flower.
Even if these cases can be put down to isolated quality control incidents, there remain concerns over the diversity of product that is available from this government source. While there is a range of cannabis potencies available for researchers to choose from, the most potent of these is only 13% THC. This limits the ability of researchers to emulate real-world conditions in their studies, as there are many popular strains of commercially available cannabis that regularly test as containing around 20% THC.
Additionally, the government source can only supply bulk cannabis and a limited supply of cannabis or placebo cigarettes. With the rising popularity of other forms of cannabis intake, such as the use of cannabis oils or resins, the inability of cannabis scientists to access such cannabis materials creates a significant knowledge gap in the field of cannabis research.
The Californian study
Dr. Fatta Nahab, a neurologist at UC San Diego, and the principal investigator for the study, has been studying neurological essential tremors for many years. He says that the idea to examine the effects of cannabis on tremors stems from a discussion he once had with a patient he had been monitoring, whose condition suddenly improved between check-ups
When Dr. Nahab questioned the patient further he disclosed that he had smoked some cannabis the night before the check-up. Later, Dr Nahab also encountered an elderly patient whose tremors had improved after she started self-medicating with cannabidiol, the major non-psychoactive component of cannabis. These meetings convinced Dr Nahab that formal scientific study into the effects of cannabis on neurological tremors was absolutely necessary.
Essential tremor (ET) affects around 4% of those aged over 65 years old and is distinctly different from other tremor disorders such as Parkinson’s disease. ET causes tremors during the voluntary or postural movement of limbs; severe tremors can greatly affect the patient’s ability to function independently. Due to the elderly demographic and the negative effects that ET can have on a patient’s fine motor control, it quickly became clear to the UC San Diego research team that study participants would likely feel uncomfortable with, or simply be unable to, administer cannabis therapy by smoking cannabis flower.
As cannabis flower is the only cannabis product currently available in the U.S., the research team sought permission from the government to import medical-grade oral cannabis capsules from the Canadian cannabis company Tilray Inc. After a lengthy approval process, the research team has now secured approval from both the FDA and the Drug Enforcement Authority (DEA) and will be able to import the capsules across the border. The final step in the approval process will be for Tilray Inc. to secure similar approval from Health Canada, but it is thought that this will be a simple process and approval will be given in the next few weeks.
It is hoped that capsules will make it easier for researchers to ensure that study participants are being given consistent and reproducible dosages of cannabis, as well as making it easier for patients to self-administer their own cannabis treatment when they are experiencing tremors.
The study is expected to begin in early 2019 and will consist of 16 to 20 patients with ET being given Tilray’s oral cannabis capsules containing a 20:1 ratio of CBD to THC. Any improvement or worsening in tremors will be assessed electronically through motion detectors that can be worn on the wrist.
In addition to providing the capsules, Tilray Inc. is also providing limited financial support to the study but will have no part in reviewing the results of the study. The study is also being partially funded by the International Essential Tremor Foundation.
Setting a precedent
Cannabis’ status as a Schedule 1 drug has previously stopped cannabis material being imported into the United States. By allowing this study to be exempt from these rules on account of the desired material not being available in the U.S., this decision could set an important precedent for other research studies who wish to use other forms of cannabis than those that are currently available in the U.S.
While rare import permits may be a good short-term fix to the inadequate cannabis product range accessible to researchers, it is certainly not a long-term solution. For that reason, cannabis researchers are keeping an eye on the Medical Cannabis Research Act as it moves through the House and the Senate. If it becomes a law, it will require the Attorney General to implement a system that would grow the number of licensed cultivators for research by at least two facilities per year until there is an adequate supply of cannabis and diverse cannabis products for research.
Challenges in accessing cannabis for research purposes
Under current U.S. policy, there is only one licensed cannabis provider for American cannabis research, a department within the University of Mississippi, which operates under a contract with the National Institute on Drug Abuse (NIDA). The University maintains a small crop of cannabis on behalf of NIDA that is grown and harvested in order to fill the demand from research projects that have been granted approval by the U.S. Food and Drug Administration (FDA) or the National Institutes of Health (NIH).
Questions have been raised about whether the quality of this governmental cannabis is suitable for use in research. Recently, there has been at least one high-profile case where a shipment of government cannabis was found to contain excessive cannabis leaf and stem matter (which is not typically used in cannabis consumption or scientific study) and some traces of mold on the cannabis flower.
Even if these cases can be put down to isolated quality control incidents, there remain concerns over the diversity of product that is available from this government source. While there is a range of cannabis potencies available for researchers to choose from, the most potent of these is only 13% THC. This limits the ability of researchers to emulate real-world conditions in their studies, as there are many popular strains of commercially available cannabis that regularly test as containing around 20% THC.
Additionally, the government source can only supply bulk cannabis and a limited supply of cannabis or placebo cigarettes. With the rising popularity of other forms of cannabis intake, such as the use of cannabis oils or resins, the inability of cannabis scientists to access such cannabis materials creates a significant knowledge gap in the field of cannabis research.
The Californian study
Dr. Fatta Nahab, a neurologist at UC San Diego, and the principal investigator for the study, has been studying neurological essential tremors for many years. He says that the idea to examine the effects of cannabis on tremors stems from a discussion he once had with a patient he had been monitoring, whose condition suddenly improved between check-ups
When Dr. Nahab questioned the patient further he disclosed that he had smoked some cannabis the night before the check-up. Later, Dr Nahab also encountered an elderly patient whose tremors had improved after she started self-medicating with cannabidiol, the major non-psychoactive component of cannabis. These meetings convinced Dr Nahab that formal scientific study into the effects of cannabis on neurological tremors was absolutely necessary.
Essential tremor (ET) affects around 4% of those aged over 65 years old and is distinctly different from other tremor disorders such as Parkinson’s disease. ET causes tremors during the voluntary or postural movement of limbs; severe tremors can greatly affect the patient’s ability to function independently. Due to the elderly demographic and the negative effects that ET can have on a patient’s fine motor control, it quickly became clear to the UC San Diego research team that study participants would likely feel uncomfortable with, or simply be unable to, administer cannabis therapy by smoking cannabis flower.
As cannabis flower is the only cannabis product currently available in the U.S., the research team sought permission from the government to import medical-grade oral cannabis capsules from the Canadian cannabis company Tilray Inc. After a lengthy approval process, the research team has now secured approval from both the FDA and the Drug Enforcement Authority (DEA) and will be able to import the capsules across the border. The final step in the approval process will be for Tilray Inc. to secure similar approval from Health Canada, but it is thought that this will be a simple process and approval will be given in the next few weeks.
It is hoped that capsules will make it easier for researchers to ensure that study participants are being given consistent and reproducible dosages of cannabis, as well as making it easier for patients to self-administer their own cannabis treatment when they are experiencing tremors.
The study is expected to begin in early 2019 and will consist of 16 to 20 patients with ET being given Tilray’s oral cannabis capsules containing a 20:1 ratio of CBD to THC. Any improvement or worsening in tremors will be assessed electronically through motion detectors that can be worn on the wrist.
In addition to providing the capsules, Tilray Inc. is also providing limited financial support to the study but will have no part in reviewing the results of the study. The study is also being partially funded by the International Essential Tremor Foundation.
Setting a precedent
Cannabis’ status as a Schedule 1 drug has previously stopped cannabis material being imported into the United States. By allowing this study to be exempt from these rules on account of the desired material not being available in the U.S., this decision could set an important precedent for other research studies who wish to use other forms of cannabis than those that are currently available in the U.S.
While rare import permits may be a good short-term fix to the inadequate cannabis product range accessible to researchers, it is certainly not a long-term solution. For that reason, cannabis researchers are keeping an eye on the Medical Cannabis Research Act as it moves through the House and the Senate. If it becomes a law, it will require the Attorney General to implement a system that would grow the number of licensed cultivators for research by at least two facilities per year until there is an adequate supply of cannabis and diverse cannabis products for research.
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