By: Dr. Karen Keough, Board-Certified Neurologist/Epileptologist and Chief Medical Officer, Compassionate Cultivation
In June of this year, the Texas state legislature expanded the Compassionate Use Act to allow medical cannabis as a potential treatment for a number of new conditions – thereby opening the program to a significant number of qualified physicians throughout the state. Below we have provided a bit of history, as well as some additional details, to help physicians in Texas know how to expand their knowledge about medical cannabis for your patients.
Medical Cannabis and its Two Key Compounds: CBD and THC
The human endocannabinoid system (ECS) was discovered in the 1990s from research on the effects of cannabis on the human body. Very simply, the body has two types of receptors which serve to moderate a wide range of systems including memory, mood, motor function and how you experience pain. CB1 receptors are most commonly found in the brain and central nervous system. CB2 receptors are most commonly found in our immune system.
These receptors play an important regulatory role in many physiological processes such as our mood, our energy level, our intestinal fortitude, immune activity, blood pressure, bone density, glucose metabolism, how we experience pain, stress, hunger, and more. When the endocannabinoid system doesn’t function properly, our bodies respond adversely. Science has shown that proper regulation of the endocannabinoid system is disabled in nearly all pathological conditions.
Cannabis is a plant that produces a thick substance containing over 100 compounds called cannabinoids. CBD (cannabidiol) and THC (tetrahydrocannabinol) are the most common cannabinoids found in cannabis. THC and CBD are produced in marijuana and hemp. Both CBD and THC work with receptors that release neurotransmitters in your brain.
A Brief History of Cannabis as Medicine
As covered in the journal Pharmacy & Therapeutics, “cannabis is a plant with origins tracing back to the ancient world. In the U.S., cannabis was widely utilized as a patent medicine during the 19th and early 20th centuries, described in the United States Pharmacopoeia for the first time in 1850. Federal restriction of cannabis use and cannabis sale first occurred in 1937 with the passage of the Marihuana Tax Act. Subsequent to the act of 1937, cannabis was dropped from the United States Pharmacopoeia in 1942, with legal penalties for possession increasing in 1951 and 1956 with the enactment of the Boggs and Narcotic Control Acts, respectively, and prohibition under federal law occurring with the Controlled Substances Act of 1970. Beyond criminalization, these legislative actions contributed to creating limitations on research by restricting procurement of cannabis for academic purposes.”
In 1996, California became the first state to permit legal access to and use of botanical cannabis for medicinal purposes under physician supervision with the enactment of the Compassionate Use Act. By January 1, 2019, 36 states as well as Washington, D.C., Guam, and Puerto Rico will have enacted legislation governing medicinal cannabis sale and distribution; 21 states and the District of Columbia will have decriminalized marijuana and eliminated prohibition for possession of small amounts, while eight states, including Alaska, California, Colorado, Maine, Massachusetts, Michigan, Nevada, Oregon, and Washington, as well as the District of Columbia, will have legalized use of marijuana for adult recreation.
Each state has the capacity to define its own medical cannabis program and, as a result, the term has very different meanings depending on where you live and work. In Texas, the state defines medical cannabis as “low-THC” cannabis derived from the plant Cannabis sativa and any part of that plant or any compound, manufacture, salt, derivative, mixture, preparation, resin, or oil of that plant that contain not more than 0.5 percent by weight tetrahydrocannabinols or THC.
The Texas Compassionate Use Act
Originally passed into law in June 2015, the Texas Compassionate Use Act allowed for the use of low-THC medical cannabis to be used as a practical treatment for intractable epilepsy. This marked an important sea-change in the state’s stance towards medical cannabis in Texas. Historically, Texas has had one of the most restrictive legal environments for cannabis possession in the country.
In February of 2018, the state’s first dispensary opened in Manchaca, just south of Austin. One of only three licensed dispensaries in the state, Compassionate Cultivation officially began producing, processing and distributing the only authorized formulation at the time: a 20:1 ratio of CBD-to-THC. This is because clinical research studies have shown solid results in using this ratio to reduce and sometimes eliminate seizures among patients who were not responding to typical anti-seizure medications.
In June 2019, based on the success of the intractable epilepsy program, the Texas Compassionate Use Program was expanded, allowing medical cannabis as a possible treatment for a much broader set of qualifying conditions, including:
- all forms of epilepsy and other seizure disorders
- multiple sclerosis
- amyotrophic lateral sclerosis or ALS
- terminal cancer
- other neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease, and more
For a deeper dive on medical cannabis and these conditions, Compassionate Cultivation has compiled a complete repository of condition-specific medical studies here.
Other important changes in the program were, removing the requirement for a second qualified medical opinion, and eliminating the 10% by weight ‘floor’ for CBD content in products. Removing this restriction allows medical CBD producers to offer a variety of CBD:THC ratios that are more tailored to individual patients and their specific conditions.
For patients, the passage and expansion of the Compassionate Use Program (CUP) meant that, through their physician, they could now have access to a new medical regime to potentially impact symptoms such as pain, spasms, lack of appetite, restlessness and many others.
For physicians, the Texas Compassionate Use Act provides them with another medicine to help their patients deal with some of the most severe conditions.
Understanding Ratios and Formulations
Medical cannabis products are produced in a number of formulations with varying ratios of CBD and THC. To properly address some of the new conditions approved under the state of Texas’ Compassionate Use Program, licensed producers in this state are only allowed to produce cannabis extracts containing up to 0.5% THC by weight, which includes only what are referred to as High-CBD and Balanced (but not High-THC) formulations.
High-CBD formulations have much higher CBD content by weight – up to 20 times the amount of THC. Clinical research suggests that High-CBD formulations can have a positive impact on symptoms associated with conditions including epilepsy, other seizure disorders, and autism.
Balanced formulations have relatively similar levels of CBD and THC by weight. Clinical research suggests that balanced formulations can have a positive impact on symptoms associated with conditions such as ALS, terminal cancer, and many other neurodegenerative disorders. Some patients may experience several symptoms that could respond to either High-CBD formulations or balanced formulations, or a combination of both.
How Does a Doctor Register to Prescribe Medical Cannabis in Texas?
The process of registering with Texas’ medical cannabis program is understandably new to most physicians, but it’s relatively straightforward and typically takes only a few minutes. To start the process, visit the Texas Department of Public Safety Compassionate Use Registry Portal at https://curt.dps.texas.gov/app/application/physicianEmailInvitation.xhtml.
To start, enter your name and email address – this will generate an email including a link to the online application form. To register, you will need 1.) the Texas Medical Board License number, 2.) your American Board of Medical Specialties number and 3.) your Texas Driver’s License audit number. Upon completing this application, you will receive a confirmation email and tracking number. Note that verification by the Department of Public Safety can take between 1 – 10 business days. For more on registering, visit here.
How Should a Physician Approach Dosing?
Like most new medications, dosage recommendations for cannabis medicines are best established according to existing scientific research, careful integration of high-quality anecdotal evidence, and incorporation of individual patient outcomes. The process of finding the correct dose will be different for each patient, determined through a titration process guided by their physician.
As more patients join the program and the knowledge base for physicians grows, prescribers will gain a better understanding of efficacy and how patients tolerate medical cannabis treatment. Clinical studies show the starting dose for 3:1 for most targeted conditions/symptoms will range from 2.5-5mg of THC per day. For the 20:1 formulation, the starting dose for most targeted conditions/symptoms will range from 50-100mg of CBD per day in adults and 0.5-1 mg/kg/day in children.
The most important consideration in dosage and administration is to start at a very low dose and increase the dose slowly to determine the correct dose for you and to minimize side effects. People with no prior experience using cannabis medicine should be especially careful to follow this guidance.
Medically sensitive patients, such as children under two, or those taking multiple concomitant seizure medications, should be started at a lower dose and titrate more slowly. Less sensitive patients can be started at a somewhat higher initial dosage.
For best delivery of medication, a prescribed dose of the medication should be placed inside the mouth between the cheek and gums or on the tongue and allowed to be absorbed. The medication can be swallowed rather than absorbed in the mouth, but less medication will reach circulation due to first-pass hepatic metabolism. The patient will usually feel an effect within 1-2 hours and the effect will usually last 4-6 hours, or longer. Medical cannabis can sometimes have a “biphasic effect,” where at low doses there may be one effect (wakefulness) and at higher doses the opposite effect (sleepiness). This is why titration is so important.
Where Can I Learn More About Prescribing Medical Cannabis in Texas?
We have compiled an excellent repository of research on medical cannabis as it relates to the conditions approved by the Texas legislature here. For more information, please contact the dispensary at (512) 614-0343. Welcome to the program!
Dr. Karen Keough is a board-certified pediatric neurologist who specializes in treating intractable epilepsy at Child Neurology Consultants of Austin. She initiated the child neurology residency program at Dell Medical School at the University of Texas at Austin and continues to serve as faculty.
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