Trial of Cannabis for 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.

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 <60)