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.
What Is Essential Tremor – And Can CBD Oil Help?
Essential tremor, sometimes referred to as ET, is a condition that affects around 7 million Americans and millions more the world over. ET affects up to 1% of the general population, and up to 5% of people aged over 65.
Despite how common ET is, there is yet to be any cure, and there are currently very few treatment options available.
Some have proposed that CBD oil could offer potential relief to those suffering from essential tremor. This article will explore this possibility in-depth.
What Is an Essential Tremor?
Essential tremor is a nervous system (neurological) disorder. It is characterized by involuntary and rhythmic shaking, which can occur in any part of the body. It most commonly occurs in the hands when performing simple tasks like drinking from a glass or tying shoelaces.
The tremors are similar to Parkinson’s disease symptoms, which often leads to ET being confused with Parkinson’s. Some of the key differences between the two conditions are:
- The timing of the tremors
With ET, the tremors usually occur when the affected person is using their hands. However, with Parkinson’s disease, these tremors or shakes arise when they are inactive. Parkinson’s hand tremors are most prominent when they are by the person’s side or resting on their lap.
- Posture and movement
Some people with ET develop ataxia, which means that they no longer have full control over their bodily movements. As a result, people with ataxia often have an unsteady gait.
On the other hand, people with Parkinson’s disease often have a shuffling gait. Other associated symptoms of Parkinson’s disease include slow motion and having a stooped posture.
- Similarities in parts of the body affected by both conditions
ET mainly affects the hands, head, voice, and legs. With Parkinson’s disease, these tremors usually start in the hands. However, they can also impact the legs and chin.
Symptoms of Essential Tremor
Essential tremor signs and symptoms:
- Begin gradually, usually more prominently on one side of the body
- Worsen with movement
- They usually occur in the hands first, affecting one or both hands
- Can include a “yes-yes” or “no-no” motion of the head
- Emotional stress, fatigue, caffeine or temperature extremes may aggravate this condition
Upward and downward movements characterize ET in the hands. These tremors can also affect the arms, head, eyelids, and larynx (voice box), which results in a shaky voice.
Essential tremor symptoms can be challenging to detect, as they tend to start discreetly and worsen over time.
People should not confuse essential tremor with what doctors consider to be a physiologic tremor. Many people have a slight tremor only when performing specific tasks, which is entirely reasonable and nothing of concern. Factors such as caffeine, stress, smoking, and tiredness can bring on a physiologic tremor.
What Causes an Essential Tremor?
One risk factor for ET is age. Essential tremor is much more common in people aged 40 and older. And as already mentioned, ET affects up to 5% of people aged over 65.
The other main risk factor is a genetic mutation. The inherited cause of ET is due to it being an autosomal dominant disorder. This means that only one parent needs to have the defective gene for their children to inherit it. Research shows that if one parent has the defective gene, then children have a 50% chance of developing the condition.
What Treatments Are Available to Those with Essential Tremor?
There is currently no cure for essential tremors. Treatment is limited to medication or deep brain stimulation surgery in extreme cases. While there is no medication capable of completely removing the symptoms of essential tremor, some can reduce their severity. Some commonly prescribed medications include:
- Primidone (anti-seizure drug)
Could CBD Oil Help Reduce an Essential Tremor?
Cannabis research is ongoing and focuses on its potential in addressing a plethora of medical symptoms. Many states across America now have laws allowing cannabis use in some form.
Cannabidiol, or CBD, is one of the most heavily researched compounds of the marijuana plant. CBD could potentially be hugely significant in mitigating a host of disease-related symptoms in the future.
Research has shown that CBD has anti-inflammatory properties and is a patented neuroprotectant. It also displays other promising benefits.
The FDA has also acknowledged CBD’s medicinal benefits for certain types of seizures. The epilepsy drug Epidiolex is the first-ever CBD-based drug the administration has approved.
Despite the level of research into CBD, there is still minimal research into cannabis for essential tremor.
Current Research into CBD for Essential Tremor
Despite encouraging research into CBD for other conditions with similar symptoms, experts are no closer to adding essential tremor to the list of qualifying conditions for medical marijuana.
However, there has been a recent breakthrough for the industry as researchers at the University of California San Diego are currently researching the area.
They are conducting a study that will look at the effectiveness and safety of a cannabis formulation for helping ET.
The researchers estimate that approximately sixteen participants with ET would take part in the study. All participants undergo a complete neurological examination and psychological testing as part of the study.
The participants take an oral cannabis formulation with a CBD to THC ratio of 20:1. Upon completion of a particular dosage of the cannabis formulation for two weeks, participants taper off. After a washout period, they then cross to an alternate study arm.
The study will take approximately one year to complete. The researchers will use various types of validated tremor rating measures in the study. As well as quantifying tremor severity, the researchers will assess the safety and tolerability of the cannabis formulation.
Final Thoughts on CBD Oil for Essential Tremor
The research occurring at the University of California San Diego is hugely crucial for sufferers of ET and the cannabis industry as a whole. This will be the first time that scientists have looked to the plant for its effectiveness in calming essential tremors symptoms.
The results of the study could potentially have a life-changing impact on people with ET. A positive outcome would likely pave the way for further clinical studies using cannabinoids.
There has not been much research done on the potential effects of CBD for essential tremor. However, we are expecting this to soon change.