How do you research a controlled substance? You might assume that there is a lot of paperwork involved, and you would be right.
For scientists wishing to explore the possible uses of cannabis, getting hold of the materials they need can be a real headache. However, with growing interest in the medicinal benefits of this herb, it is a necessary evil.
So just how hard is it for a scientist to get access to marijuana? Let’s take a look.
The Scheduling of Marijuana
In the United States, marijuana is classed as a Schedule 1 narcotic under the 1961 international Single Convention on Narcotic Drugs. This convention classifies all substances into one of five schedules according to their therapeutic value versus their potential for abuse. Schedule 1 drugs are classed as having no therapeutic value and a high potential for abuse. They include cannabis, heroin, LSD, and other hallucinogens.
Putting pot into the same category as these harder drugs may seem a little crazy, especially when you consider that cocaine and methamphetamine are only classed as Schedule 2 drugs. Surely there is now heaps of evidence for the medicinal use of cannabis, so why is it still a Schedule 1?
The sad fact is that the scheduling system was created decades ago when the medicinal value of marijuana was largely unrecognized. If its benefits could be proven beyond doubt, there is a good chance that it could be reclassified, making it easier to obtain for research (and other) purposes.
The problem with this caveat is that, in order to definitively prove its medicinal value, any drug has to undergo large-scale trials; preferably double-blind, randomized, controlled trials (RCTs).
Double-blind RCTs are widely viewed as the gold standard for clinical trials. They require participants to be randomly assigned to receive either an active compound or a placebo, and the results of the two groups are compared. Double-blind means that neither the participants nor the researchers know who is receiving the active substance and who is getting a placebo.
Although many cannabis trials do meet these criteria, they are not considered large-scale enough for the drug to be rescheduled. Besides, many cannabis trials are not placebo-controlled, meaning that any positive results are not seen as reliable. It is clear that more high-quality research on cannabis is necessary, but getting approval for these studies is hard. It’s a catch 22 situation which does not look set to be resolved any time soon.
How Current Marijuana Laws Affect Research
Being a Schedule 1 substance means that the DEA can strictly limit access and supply, even for use in valuable research studies. This problem also affects dispensary owners and growers, even in states where marijuana is legal. Some of these entrepreneurs have been refused for bank accounts and are unable to claim certain expenses against their tax bills because they are classed as “drug trafficking.”
For scientists, the current law means that a Schedule 1 license is required before they can even think about beginning their research, but this is not easy to come by.
One such scientist is Dr. Michael Hoffer of the University of Miami Miller School of Medicine. Hoffer became interested in whether cannabinoids such as cannabidiol (CBD) could be used to treat concussions following the high-profile cases of NFL players Ralph Wenzel and Kevin Turner. Both men died from a condition known as chronic traumatic encephalopathy (CTE), which can develop after suffering repeated concussions.
This condition is surprisingly common in footballers. According to one study, a staggering 96% of NFL players could be affected by this potentially fatal disease. Hoffer believed that CBD could help due to its influence on the brain and nervous system. However, getting hold of the CBD that he needed to carry out his research was an uphill struggle. Hoffer says:
“While almost all doctors have class 2 through 5 licenses, getting a class 1 addition to your license requires a lot of paperwork.”
Scientists hoping to research cannabis or any other Schedule 1 substance will need to apply for a specific license from the Drug Enforcement Agency (DEA). As well as personal information such as the researcher’s name, address, and qualifications, they must also supply details of the proposed study. This information includes the title of the study, its intended purpose, the specific protocol, number (and species) of participants, drug, dosage, route of administration, and the duration of the study. The critical thing to consider is that the DEA needs to see a real justification for the study in order for it to be approved, and this does not come easily.
When you add all of this paperwork to the hoops that scientists already need to jump through to get any study off the ground, this extra hurdle could put off many less dedicated researchers. Facing ethics committees and recruiting suitable subjects, for example, can literally take years – and that is before the study itself has even begun!
While Hoffer and his team eventually got their research approved, many other studies fall by the wayside. This means that it is incredibly difficult for the scientific community to gather the evidence they need to get marijuana rescheduled successfully.
Getting Approval for Marijuana Research
On the plus side, the National Institute on Drug Abuse (NIDA) does recognize the need for more marijuana research to be carried out, and there is detailed information on its website about exactly which requirements must be fulfilled to get a cannabis research project off the ground.
The number one requirement is that the project must “demonstrate scientific validity and ethical soundness through NIH review.” This process involves three steps including peer review, facing an advisory council made up of leading scientists and members of the public, and a final decision made by the funding institute’s director.
Marijuana researchers must be registered with the DEA and the Food and Drug Administration (FDA) if they plan to carry out tests on humans. Scientists will also be required to demonstrate that they have adequate security provisions on site.
The license issued to marijuana researchers by the DEA is similar to the one required for retail pharmacies, hospitals, clinics, and teaching institutes. It allows the licensee to handle controlled substances as covered by their original application. The license usually takes between four and six weeks to be granted, so it is wise to get applications in early.
Who Supplies Marijuana for Research Projects?
All cannabis for research purposes must be obtained through the NIDA drug supply program, and it recommends that prospective researchers get in touch beforehand to confirm availability.
There is currently only one institution with a federal license for the cultivation of marijuana for research, and that is the University of Mississippi. The university grows its marijuana on a secure piece of land according to current and expected demand.
However, with an ever-increasing interest in the medicinal properties of weed, this single supplier is now struggling to keep up. The DEA recently agreed to allow additional growers to register to cultivate marijuana for scientific purposes, but the details of exactly how this process will work are still unclear.
The Future of Marijuana Research
It is clear that far more research is needed into the safety and efficacy of marijuana before its status as a Schedule 1 drug can change.
One institution committed to the future of marijuana research is the Center for Medicinal Cannabis Research. The center has already had an impact on marijuana research policy, and its mission statement includes goals such as:
“To facilitate high-quality scientific studies to ascertain the safety and efficacy of cannabis and cannabinoid products and examine alternative forms of administration.”
The center is currently involved in a number of studies on the effects of cannabis and cannabinoids for various conditions including anorexia nervosa, bipolar disorder, movement disorder, and neuropathic pain. This is proof that although getting approval for cannabis research is difficult, it is certainly by no means impossible.
Final Thoughts: How Hard is it for a Scientist to Get Access to Marijuana for Research?
Getting access to marijuana for research is hard work. It requires mountains of paperwork, persistence, and a whole lot of patience. However, there is a genuine need for more high-quality clinical studies to be carried out in order to get our current cannabis laws changed and make it easier to procure.
So for any budding scientists out there, please don’t be put off by how much work is required to get your cannabis research project started. Your efforts will be well worth the while!