Trial of Cannabis for Essential Tremor
A Double-Blind, Cross-Over, Placebo- Controlled Efficacy and Tolerability Study of Oral Cannabidiol (CBD) and Tetrahydrocannabinol (THC) for Essential Tremor (ET).
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.
Essential tremor (ET) is the most common neurological movement disorder, affecting up to 1% of the population and up to 5% of individuals over the age of 65. ET is characterized by often disabling tremors that occur when an individual moves. The tremors most commonly affect the hands, head, voice, and legs in order of frequency, leading to impairment in activities of daily living and morbidity. No pharmacological agent has been developed for ET, though existing agents such as propranolol and primidone are used off-label to reduce tremor amplitude. Deep brain stimulation surgery is often reserved for only individuals with the most severe tremors. Patients with ET have long reported tremor benefits with the use of cannabis, though no controlled trials have been conducted. The investigators plan to conduct the first double-blind, placebo-control clinical trial of cannabis in an oral capsule. Various validated tremor rating methods will be used to quantify tremor severity, while looking at tolerability and safety.
Intervention Type: Drug
Description: Oral formulation of CBD and THC.
Arm Group Label: CBD/THC
Intervention Type: Drug
Arm Group Label: Placebo
Inclusion Criteria: – Diagnosis of ET by a Movement Disorder Neurologist – Stable dose of tremor medication for a period of at least 6 weeks prior to screening – Tremor in the arms – Tremor(s) is/are moderately severe (amplitude of at least 1cm) Exclusion Criteria: – Significant non-ET related abnormal findings on neurological exam – Tremor at rest, or other features suggestive of Parkinson disease – Diagnosis of dementia – Pregnant or nursing – Childbearing potential and unable or unwilling to use contraception during course of the trial – On medications known to interact with the study drug – Current or prior history of alcohol or substance abuse – Recent exposure to primidone (within the past 21 days) or benzodiazepines (such as Valium, Ativan or Klonopin), ketoconazole, ritonavir, clarithromycin, rifampin, carbamazepine, St. Johns Wort, digoxin or other medications known to affect your liver enzymes (within the past 7 days). – Unwilling to abstain from consuming grapefruits, grapefruit juice or grapefruit containing products. – Taking medications such as warfarin, cyclosporine, and amphotericin B that are highly protein-bound – Do not wish to take a cannabis-derived agent – Allergy or sensitivity to sorbitol, xylitol, stevia or other natural sweeteners – Allergy or sensitivity to cannabis – Used cannabis or a cannabis-derived product (such as CBD oil) within the past 4 weeks or plan to use it during this research study. – Diagnosis of a psychiatric disorder (e.g., mania, bipolar depressive disorder, schizophrenia, schizoaffective disorder, or other major psychiatric disorder) – Current or prior history of suicidal thoughts and/or behavior – Active medical problem affecting the immune system, liver, gastrointestinal tract, lungs, heart, endocrine system (such as diabetes and/or thyroid), and/or a blood clotting disorder – Current infection – Reduced kidney function (GFR
Minimum Age: 21 Years
Healthy Volunteers: No
Type: Principal Investigator
Investigator Affiliation: University of California, San Diego
Investigator Full Name: Fatta B Nahab
Investigator Title: Associate Professor of Neurosciences
Description: Treatment arm
Type: Placebo Comparator
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
This is a pilot trial to evaluate the safety and efficacy of a combined oral formulation of THC and CBD in patients with Essential Tremor.. Clinical Trials Registry. ICH GCP.
A Complete Guide to Natural Remedies for Hand Tremors – CBD Oils Versus Gloves & Utensils
Cannabinoids such as Cannabidiol (CBS) have been looked at for its ability to relax muscles, ease seizures, and provide relief for tremor-like symptoms (1). It has been shown that cannabinoids found in the marijuana plant interact with the body’s endocannabinoid system (ECS). This system is in charge of body functions and regulating controls. It has been suggested that CBS can play a role in combination with the ECS to target cannabinoid receptors in the brain and body that control our muscles (1).
What Is the Endocannabinoid System (ECS)?
The Endocannabinoid system (ECS) is a cell signaling system within the human body that involves 3 components; endocannabinoids, receptors, and enzymes. (2)
- Cannabinoid receptors act as information antennas, letting the body know on a biochemical level how the inner cell environment is. A good example of its abilities is the interaction with tetrahydrocannabinol (THC), which tells the brain to give the user a high feeling (3).
- Endocannabinoids are molecules produced within the body, similar to cannabinoids. The endocannabinoids help the body to remain in homeostasis or a healthy state (3).
- Enzymes on the other hand help to regulate the body, they break down endocannabinoids once they are used so that they don’t continue to affect the body (3).
This system was discovered while exploring the effects of THC, a cannabinoid found in cannabis (marijuana). Regardless of whether one uses cannabis or not, the ECS is active and plays a role in functions and processes within the body such as, sleep, mood, appetite, memory, pain, reproduction and fertility (2). It is activated when the body is stressed, strained, or injured. The ECS then releases endocannabinoids that help to bring the body back to its base resting state where it is balanced again (2).
What are CBD Oils?
Cannabidiol (CBD) is the second most prevalent active ingredient of cannabis (marijuana). While CBD is an essential component of marijuana, it is derived directly from the hemp plant, which is a cousin of the marijuana plant. The hemp plant has two major components; the Cannabidiol (CBD) and Tetrahydrocannabinol (THC), CBD is extracted and made into an oil with very low concentrations of THC therefore exerting no psychotropic effects (4). CBD however, does have a number of non-mood-altering effects including fatigue, nausea, irritability, and it can also increase the amount of blood thinner in your blood. (5) THC is known to relax, enhance sensory activity, reduced aggression, and most often lead to a sense of fatigue and hunger, CBD on the other hand is proposed to have many therapeutic properties with low risks (3). CBD studies have connected its ability to alleviating symptoms and side effects for chemotherapy, multiple sclerosis (MS), epilepsy, calming anxiety, glaucoma, controlling tremors associated with Parkinson’s Disease (PD), brain and spinal injuries, and contains anti-inflammatory properties (3). Essential tremor is another condition that is being tied to CBD use however, its application has not been proven to be effective just yet, it is under research (6). It is notable that the Food and Drug Administration (FDA) has acknowledged CBD’s medicinal benefits (1). The epilepsy drug Epidiolex is the first-ever CBD-based drug the organization has approved (1).
Characteristics of Essential Tremor & Parkinson’s Disease
Essential tremor (ET) is a disorder of the nervous system that is characterized by involuntary and rhythmic shaking within the body. Most commonly, it occurs in the hands making simple takes such as eating and drinking difficult (1). However, it is known to also affect the arms, head, face and larynx. These tremors can start at a mild range and grow to become severe overtime (6).
Parkinson’s Disease (PD) is a long-term disorder of the central nervous system and is characterized by stiffness, trembling of limbs, imbalances of the limbs, and loss of muscle control (7). The typical Parkinson’s Disease tremor is known to show itself when at rest, and subsides when the body part is in use or active (8). For example, your hand may shake when sitting, however, when you go to shake another individual’s hand, the hand tremor becomes less severe or disappears (8). The tremors can occur in the hand, lower lip, jaw, or legs and can interfere with daily activities such as dressing, walking and other fine motor skills (8). These tremors have a slow progression and are less common among younger people with PD (8).
The biggest difference between PD tremors and other tremors is that PD tremors are resting tremors versus other conditions are characterized by active tremors; tremors that lessen at rest and increase when one is doing something (8).
How Can CBD Play A Role in Your Hand Tremor Management?
When using CBD oil for hand tremors the CBD in the oil can target and regulate the ESC receptors which are responsible for muscle movement (6). These receptors are located in the brain and body. The regulation of these receptors allows CBD oil to relax, reduce inflammation, and ease symptoms of tremors (6). There have been studies that confirm these interactions and confirm that CBD can effectively act as a neuroprotectant (6).
In a study conducted by Dr. Handforth, CBD is tested in a variety of doses and it is noted that robust suppression of tremor in mice is possible, without showing any signs of impairment or sedation (9). The research team also went on to discover what receptors in the brain may be involved in the noted effects. It was suggesting that CBD activates the 5HT1a receptors to suppress tremor by activating the TRPV1 receptor (9).
Individuals affected by hand tremors find it difficult to complete hand-related tasks because of the consistent shaking. A recent discovery for CBD use is its potential in treating hand tremors. People with shaky hands have started making use of the CBD’s anti-tremor mechanisms, many of which have found that daily doses of CBD products are successful in managing their symptoms (10). Many of the prescription drugs used to treat essential tremors can sometimes affect mood or cause depression (10). CBD is an alternative natural remedy with anti-tremor capabilities that has a good safety profile, along with minimal side effects (10).
In order to have the best experience when using CBD, it is crucial that one does their research on which brands are trustworthy and best fit your condition. CBD is offered by a variety of brands which differ in application methods such as oils, balms, creams, edibles and vape (10). Furthermore, it is very important that you read the product labels and descriptions thoroughly to make sure that contents are present, active and not altered in any way (11). You should be aware of products with high amounts of THC or products that don’t actually contain CBD (10). Please keep in mind that CBD generally is known to have few side effects, it is still recommended that one should consult a neurologist or physician who knows your medical history before using it. The doctor may be able to assist with the correct dosage according to the method of administration for your condition while making sure that it does not have a negative effect on the pre-existing medication you are taking, if any (10).
Using CBD For Hand Tremors (Dosage and Use)
The two most popular ways of taking CBD for hand tremors is using a CBD oil or vaping the CBD. Everyone reacts differently to CBD so it is crucial to experiment with the method and amount used to see what works best to relieve your particular hand tremor condition (6). It is suggested that one should start with a low dosage such as 1 drop, 3 times a day and increase it according to your tolerance and how much relief it provides (6). On an average, about 25mg is a good amount for someone with non-severe symptoms (6). It is important to note that depending on the product, the CBD content should be used with caution as no single ratio is right universally. CBD comes in 2 forms that work for hand tremors; CBD oil, which comes in a bottle with a dropper. A drop or two is placed under the tongue to allow the oil to absorb into the body. It also can be used as a Vaping CBD, these are E-Liquids available to incorporate into the vape pen. This allows for a quicker pathway into the body and hence the fastest way to experience the effects. The vapor enters the lungs first and reaches the bloodstream immediately.
Which CBD Oil Is Right for You?
There are many CBD oils on the market however, it is very important to differentiate that not all of them are made equally. There are no CBD products currently approved by the FDA, and nor are all of them equally as effective (12). When deciding to use CBD products be aware of any negative and positive reactions. If your on the market to purchase CBD oils here are some tips to keep in mind while exploring all the options available:
Tips for When Shopping for CBD Oil
- Look for products that have been made by a state that have legalized recreational/ medical use of cannabis (13) and for products derived from high-resin cannabis grown sustainably in accordance with Regenerative Organic Certification (ROC) standards (13). Keep in mind that locally grown products will most likely be more expensive than imported products (14).
- Look for full spectrum CBD oil extracts that contain less than 0.3% of THC (12). Full spectrum represents numerous cannabis compounds, it does not isolate only the CBD. If you choose to not have THC in your CBD oil you can look for broad spectrum CBD oil products that include other cannabis components except for THC (13)
- Reach out to the brands directly if you have questions, do not shy away. If you do not get a response look for another brand that will provide answers.
- Look at the product labels to see if it indicates the amount of CBD and THC per dollar (13).
- Look out for CBD vape cartridge products with harmful ingredients such as thinning agents; propylene glycol and polyethylene glycol (13).
- Beware of claims of CBD being derived from the seed or stalk of the hemp plant. CBD is not found in hemp seed and very little can be extracted from the stalk (13).
- Look for products that were tested by a third-party laboratory (13) . Certificates for analysis from these third-party laboratories require paid tests and are important in determining the CBD quality (14).
- Make sure it is meant to be taken orally (12).
- Look on the product to make sure it indicates a manufacturing date and a batch number (13)
Top 10 CBD Oils
If you want to take a dive into CBD oils, here is a list of 6 featured on Huffpost’s list of best CBD products (15). The following brands offer more than just CBD oils however for the purpose of this blog topic surrounding Hand tremors we will be looking specifically at brands that offer CBD products in Oil form.
CBD Oils Versus Gloves & Utensils for Hand Tremors
CBD oils are used within the body to help a variety of conditions and symptoms. Currently, on the market they are a fairly new product and require a lot more investigation and research to recommend as a management tactic for ET and PD Hand tremors (14). Some research shows that CBD can play a role in tremor management however, it is not supported by a governed body just yet for hand tremors specifically due to ET. As a result of the uncertainty of CBD’s effects it might be worth checking out other alternative solutions before diving into products that may have side effects on the body in the short and long-term.
It might be worth checking out assistive devices that are used externally on the body part that is tremoring to help improve daily activities. On the market currently there are a large variation of assistive devices available that cater to specific tasks such as, the Liftware steady spoon that helps to improve daily eating, and then there are some that aid in a vast number of activities such as, the Steadi-One glove that is designed to help perform multiple tasks that one may struggle with throughout the day.
The following table weighs out the positive and negative aspects of each type of product and our suggested rating for each product type that is available and you should further look into.
Cannabinoids such as Cannabidiol (CBS) have been looked at for its ability to relax muscles, ease seizures, and provide relief for tremor-like symptoms (1). It has been shown that cannabinoids found in the marijuana plant interact with the body’s endocannabinoid system (ECS). This system is in charge of body functions