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.
CBD for Tremors
Are you looking for plant-based solutions to your tremors? Tremors occur for different reasons in different parts of the body. What’s the most common form of tremor? We’ll get to that in a minute.
What are tremors?
Tremors are muscle movements that involve and back and forth rhythmic swaying. I think you’ll agree with me that those who experience them seem to be uncomfortable. In today’s post, we’ll explore what tremors are and what we know about them.
Best CBD Oils For Tremors
Are tremors really that out of control?
Tremors are involuntary and can impact the legs, hands, arms, head, face, body, and voice. Generally, tremors are caused by neurological dysfunction in the brain affecting how muscles are controlled. Conditions that destroy or degrade the brain like stroke or a brain injury can cause tremors.
Tremors can occur in otherwise healthy people. Those with tremors may experience anxiety or embarrassment because they are visible and can affect one’s motor skills. The rhythmic shaking may be exacerbated by stress or environmental triggers making the motions more extreme and uncoordinated.
Tremors can also occur in reaction to certain prescription drugs or alcohol withdrawal. They can be inherited or appear seemingly randomly. Tremors affect men and women equally and tend to be found in middle age to older people, although anyone can experience them.
The two types of tremors
Tremors can be classified in two different ways. A resting tremor is when shaking occurs even when a person or muscle is at rest. Parkinson’s patients commonly experience these — their hands will shake even if they are laying down and their hands are resting on their lap. Resting tremors can occur in any area of the body but are most commonly found in the hands and fingers.
Action tremors are a bit more complicated. Action tremors — you guessed it — occur when the individual or affected body part is in motion. There are several subtypes of action tremors. According to the National Institute of Health, there are 5 different action tremor subtypes:
- Postural tremor occurs when a person holds a position against gravity, such as outstretching the arms
- Kinetic tremor is associated with any voluntary movement like opening and closing the eyes
- Intention tremor occurs with purposeful movement towards a target, like reaching to grab something, these can get worse as the person gets closer to the target
- Task-specific tremors occur when performing highly-skilled goal-oriented tasks like writing or speaking
- Isometric tremor occurs during a voluntary muscle contraction that is not accompanied by any movement, like holding a bag
Doctors will evaluate tremors based on neurological and physical examination. Doctors will examine where the tremor occurs in the body when it occurs (acting or resting), and the frequency and amplitude of the tremors. Those with Parkinson’s commonly experience tremors. In a blog post on the Cleveland Clinic’s website, Hubert Fernandez, MD, Director of the Cleveland Clinic’s Center for Neurological Restoration, states, “ Parkinson’s motor problems are quickly recognizable. The tremors — rhythmic movement of lips, chin, hands, and legs; rigidity; stiffness and slowness are hallmark signs. Balance and gait problems are also common. But, Parkinson’s symptoms start long before these problems emerge. As a progressive disease, Parkinson’s destroys the brain’s nerves from the bottom up.” He also states that “only a neurologist can diagnose Parkinson’s” and encourages those who may think they have Parkinson’s to get a neurologist involved earlier.
How are tremors being treated?
There is generally no cure for tremors, but symptoms can be managed given a proper and accurate diagnosis. In some cases, they can be stopped entirely if the underlying cause is removed. For example, those who experience tremors as a side effect of medication or who have a hyperthyroid may see a total change by stopping the medication and balancing the thyroid. For degenerative diseases like Parkinson’s, this is not the case. It’s important to have a thorough testing done to find out the underlying cause.
Here’s what it boils down to:
Tremors can be treated through either medication, surgery, or lifestyle changes. Beta-blocking drugs, anti-seizure medications, tranquilizers, injections, and Parkinson’s disease medications can all treat tremors. In severe cases, surgery may be called for especially for those who don’t respond to drug treatment. Deep brain stimulation (DBS) is the most common form of surgical treatment for tremors and is preferred because it is low risk and effective. DBS sends electrical signals to the thalamus, an area of the brain that coordinates involuntary movements. Another surgical option, a thalamotomy, involves exact removal of a small area of the thalamus.
Patients may also make lifestyle changes in physical, speech, and occupational therapy. Seeing licensed professionals can help people improve their muscle control through training and exercises. In addition, removing stimulants like caffeine or tremor-inducing medications can help as well.
Is there an alternative way?
People are increasingly turning to plant medicine for a low-cost, holistic approach to treating their tremors. Anti-seizure medications and tranquilizers are common prescriptions to treat tremors that can have heavy side effects on the body. Cannabis and CBD are also anti-seizure compounds that can have tranquilizing effects that tend to soothe the body.
In regards to Parkinson’s, Dr. Fernandez states, “it’s important to remember that everyone’s experience with Parkinson’s is different, and treating it is about targeting the symptoms,” he says. “The most important thing is getting a good evaluation by a neurologist or Parkinson’s expert to make sure you’re on the right path.” He emphasizes that treatment is symptom dependent and drugs are prescribed based on how much the tremors interfere with someone’s life.
The cause of Parkinson’s is largely unknown, but doctors do know that dopamine is not produced in high enough quantities in Parkinson’s patients. Dopamine, a neurotransmitter, is naturally produced in the brain and is important in regulating movement in the body. CBD interacts with dopamine receptors and opioid receptors, but more research is needed to thoroughly understand this reaction.
So what’s the most common form of tremors?
Hand Tremors. Hand tremors are the most common form and can make the quality of life really difficult for those who experience them. Writing and motor tasks, like drinking, can be tough and people who live with tremors may experience anxiety and depression, which is also impacted by CBD and cannabinoids.
It’s really important to understand what is causing your tremors and what your treatment options are. Cannabis as medicine is exploding in popularity in places like the United States where it is used to treat seizures, chronic pain, and neurological disorders like Post Traumatic Stress. It’s important to stay proactive about your health and learn as much as possible through trained professionals about your specific conditions.
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